Clinical Research Directory

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes. In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.

AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)

Chest pain is among the most common reasons people attend an emergency department, and the electrocardiogram (ECG) recorded at triage is the first test used to decide who needs urgent treatment for a blocked coronary artery. Recognising the ECG patterns that indicate an acutely blocked artery is difficult. Many such patterns do not produce the classic ST-segment elevation, and identifying them reliably requires a level of ECG expertise that is not always available at the point of triage - particularly at night and among clinicians who are not cardiologists. Artificial intelligence (AI) models that read the 12-lead ECG have been shown in several retrospective studies, mainly from Western Europe and the United States, to identify acute coronary occlusion more sensitively than conventional interpretation. These models are now in clinical use in a number of health systems. Their performance has not been assessed in a prospectively enrolled, unselected Slovenian emergency department population, and diagnostic accuracy commonly declines when a model is applied outside the setting in which it was developed. TRIACS is a prospective, single-centre, observational external validation study in the Emergency Department of University Medical Centre Maribor. All consecutive adults presenting with symptoms suggestive of acute coronary syndrome who have a 12-lead ECG recorded at triage as part of routine care will be enrolled. Each triage ECG is analysed by the AI model. The model's output is withheld from all treating clinicians and plays no part in patient care; every patient receives standard guideline-directed management. The main aim is to measure how accurately the AI model identifies angiographically confirmed occlusion myocardial infarction in this population, and to compare its accuracy with the triage decision actually made by the clinical team. The study is therefore designed to inform an adoption decision in either direction, rather than to demonstrate a predetermined conclusion.

STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT

Primary percutaneous coronary intervention (PCI) is the preferred revascularization strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Compared with bare-metal stents (BMS) and early-generation thick-strut polymer-based drug-eluting stents (DES), newer-generation DES with thinner strut stent platforms and durable or biodegradable polymers have been shown to improve long-term safety and efficacy outcomes among patients with STEMI. Accordingly, the use of newer-generation DES over BMS is currently recommended by the most recent guidelines. Vessel healing at the culprit site after DES implantation is however substantially delayed in patients with acute STEMI as compared to those with chronic coronary syndromes and is associated with a long-term risk for recurrent stent-related adverse clinical outcomes. These findings highlight the need for future iterations in modern DES technology to further improve clinical outcomes following PCI in this highest-risk patient subset. Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a potent P2Y12 receptor inhibitor for 12 months after primary PCI for STEMI, unless there are contraindications such as excessive risk of bleeding. A recent meta-analysis of five large-scale randomized clinical trials including a total of 32'145 patients, of whom 4,070 (12.7%) patients were treated for STEMI, indicated that 1-3 months of DAPT followed by P2Y12 inhibitor-based single antiplatelet therapy (SAPT) after second-generation DES implantation in patients with chronic and acute coronary syndromes was associated with lower risk for major bleeding and similar risk for stent thrombosis, all-cause death, myocardial infarction, and stroke compared with conventional DAPT. These findings suggest that a potent P2Y12 inhibitor-based SAPT following a short DAPT course (1-3 months) may represent a preferable treatment option, which is associated with similar ischemic, but lower bleeding risk, for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT. The question of whether SAPT using a potent oral P2Y12 inhibitor (ticagrelor or prasugrel) without aspirin (aspirin-free strategy) after primary PCI with a newest-generation thin-strut polymer-free drug-eluting stent is safe and effective compared to a conventional guideline-recommended 6- to 12-month DAPT course among patients with STEMI remains uncertain.

CRP Apheresis in STEMI

Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction. Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI. Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design. Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.

Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

The goal of this observational study to measure the heart's microvascular function in the setting of a myocardial infarction (MI), or heart attack, using a method called continuous saline thermodilution (CST). The participants will include people who are experiencing MI from sudden and complete blockage of a coronary artery requiring immediate balloon and/or stent therapy. After getting the balloon and/or stent therapy, participants will have their heart's microvascular system tested using CST. The main questions it aims to answer are: * What measurements using CST can we expect from the heart's microvascular system during a treated MI? * Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers? For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.

A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026. The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells as an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.

Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction

GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST Elevation Myocardial Infarction (STEMI).

Smartphone AI Assistance for Prehospital ECG Interpretation

Prehospital providers interpret 12-lead electrocardiograms (ECGs) under time pressure and without immediate expert support. Missed acute coronary occlusion - occlusion myocardial infarction (OMI) - delays reperfusion, while false positive interpretations trigger unnecessary catheterization laboratory activations. Multimodal large language models (LLMs) available on any smartphone can now analyze a photographed ECG, and prehospital providers have begun using them spontaneously. No randomized trial has evaluated whether this practice improves diagnostic performance. This randomized controlled trial compares the diagnostic performance of prehospital providers interpreting ECG clinical vignettes with and without mandatory assistance from a single, version-locked smartphone large language model. Participants - paramedics, emergency medical technicians, nurses and physicians practicing in prehospital care in French-speaking Switzerland - are randomized 1:1 on a dedicated digital platform and answer 14 clinical vignettes presented in individually randomized order. Each vignette is built around a real, anonymized 12-lead ECG obtained during routine clinical care. The primary outcome is the proportion of vignettes for which the participant correctly identifies the presence or absence of an OMI. Secondary outcomes are sensitivity, specificity, and the accuracy of the prehospital priority decision level.

CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)

The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.

European Survey of Cardiovascular Disease Prevention, Diabetes and Chronic Kidney Disease (EUROASPIRE VI)

The goal of this observational study is to provide a unique European picture of preventive action by cardiologists, other specialists and primary care physicians looking after patients with coronary heart disease (CHD), individuals at high cardiovascular disease risk and all those with hypertension, dyslipidaemia (including familial hypercholesterolaemia), diabetes and dysglycaemia and chronic kidney disease (CKD) and determine whether the European guidelines on cardiovascular disease prevention, hypertension, lipids, diabetes and chronic kidney disease are being followed.

Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

The EPIVER Randomized Controlled Trial

The trial aims to estimate the efficacy and safety of the intracoronary administration of adrenalin, verapamil, as well as their combination compared to standard treatment in patients with STEMI and refractory coronary no-reflow despite conventional treatment during percutaneous coronary intervention (PPCI)

Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction

Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.

Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time. Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack. Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA). If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies: * Study group: reduced stent PCI strategy (DCB-based) * Control group: conventional PCI strategy (DES-based).

OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts

The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

The purpose of is study is to investigate whether ischemic postconditioning (iPOST) and intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

Early Discharge Pathway Registry

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide. Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.

Dapagliflozin in STEMI

The goal of this clinical trial is to assess the safety and efficacy of SGLT2i in limiting infarct size in patients with STEMI referred for PPCI. Eligible STEMI patients enrolled into the trial will be randomized to a SGLT2i or placebo. Cardiovascular Magnetic Resonance (CMR) imaging will be used to determine the infarct size.

Cell Free DNA in Cardiac Sarcoidosis

Sarcoidosis is a multisystem granulomatous disease of unknown cause that can affect any organ in the body, including the heart. Granulomatous myocarditis can lead to ventricular dysfunction and ventricular arrhythmias causing significant morbidity and mortality. Immunosuppressive therapy (IST) has been shown to reverse active myocarditis and preserve left ventricular (LV) function and in some cases improve LV function. In addition, IST can suppress arrhythmias that develop due to active myocarditis and prevent the formation of scar. The potential role of cardiac biomarkers, including brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), and cardiac troponins, in detecting active myocarditis is limited and studies have been disappointing. At present, there are no biomarkers to detect active myocarditis and the use of advanced imaging modalities (FDG-PET) for assessing and monitoring active myocarditis is not feasible or practical and is associate with high radiation exposure. As such, a biomarker that is reflective of active myocarditis and that is cardiac specific will assist physicians in assessing the presence of active myocarditis to guide therapeutic decisions and to assess response to therapy which can limit further cardiac damage. Cell free DNA (cfDNA) are fragments of genomic DNA that are released into the circulation from dying or damaged cells. It is a powerful diagnostic tool in cancer, transplant rejection and fetal medicine especially when the genomic source differs from the host. A novel technique that relies on tissue unique CpG methylation patterns can identify the tissue source of cell free DNA in an individual reflecting potential tissue injury. We will be conducting a pilot study to explore the utility of this diagnostic tool to identify granulomatous myocarditis in patients with sarcoidosis.

Rivaroxaban for Slow Coronary Flow After PCI in STEMI

The goal of this clinical trial is to learn if drug Rivaroxaban works to improve slow flow in STEMI patients after PCI in adults. It will also learn about the safety of drug Rivaroxaban. The main questions it aims to answer are: Does drug Rivaroxaban Reduce the Corrected TIMI Frame Count (cTFC) in 1 Week After PCI ? Researchers will compare Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) to Dual Antiplatelet Therapy to see if drug Combination therapy with rivaroxaban, aspirin works to treat Slow Flow in STEMI Patients After PCI. Participants will: Take drug Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) or Dual Antiplatelet Therapy every day for 1 months. Visit the clinic in 7 days、30 days and 365 days for checkups and tests.

Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease

Most heart attacks occur because a clot forms in a coronary artery blocking blood flow. Without blood heart muscle dies. Untreated, clots can cause a specific type of heart attack -ST-elevation myocardial infarction (STEMI). STEMI patients are treated immediately by finding the blocked artery ("culprit" lesion) using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents. This procedure - primary angioplasty - is offered 24/7 and limits the size of heart attacks and saves lives. Cardiologists know how to treat STEMI patients but it's less clear what to do about narrowings in other coronary arteries ("bystander" disease). This is important - if they're left alone some bystander lesions can cause future events including heart attacks or angina. Recent trials compared stenting ALL the bystander narrowings after primary angioplasty, with stenting none and showed some benefit from stenting all of them ("complete revascularisation"). However, complete revascularisation carries extra risk, putting patients through more complicated procedures and using up resource. A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events. In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event, and those unlikely to do so. The study can then test the hypothesis that only the high-risk bystander narrowings need stenting, and the others can be treated with tablets only. Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not. If this can be done, a case can be made to test complete revascularisation only in bystander narrowings that look high risk.