Clinical Research Directory

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

The SORT OUT IX STEMI OCT Trial

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).

Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"

Rationale: Patients with acute coronary syndromes are at an increased risk for recurrent adverse coronary events, particularly during the early period following their initial presentation. Early (in-hospital) initiation of high-intensity statins reduces the risk of recurrent events and is therefore recommended by the best current practice guidelines.(1,2) However, the delayed onset of action of statin therapy and given the frequent failure of patients to achieve the recommended LDL-C targets using statins alone (as per the current practice guidelines recommendations), might be placing large number of patients at increased risk during such a vulnerable period early after an ACS.(3) More rapid and effective reduction of LDL-C levels using combination therapy from the outset may therefore be beneficial in these patients. This hypothesis has been tested with combining Evolocumab and a statin in the recent EVOPACS study, in which this combination after ACS has shown to be safe and more effective in achieving LDL-C targets at 6 weeks compared to statin monotherapy.(4) However, Evolocumab (a PCSK9i) is an expensive drug which is not affordable by many healthcare systems in low- and middle-income countries. Ezetemibe, on the other hand, is a safe and a cheap drug that can prove to be extremely cost-effective if a meaningful and timely reduction in LDL-C levels can be achieved when combined with a statin early after an ACS. Study population Patients presenting with acute myocardial infarction, with baseline LDL-C levels not likely to achieve recommended targets on statin monotherapy. This is assumed to be with LDL-C level \> 125 mg/dl for those not on lipid lowering therapy; or with LDL-C \> 100 mg/dl on moderate intensity statin therapy at the time of presentation. Study design Prospective randomized controlled single-blinded trial. A sample size of 500 patients, 250 in each arm, was calculated to provide a power of 0.9 and an adjusted type 1 error as 0.05. Primary outcomes * Percentage of patients achieving target LDL-C levels (\<70 mg/dl) at 6 weeks interval. (Efficacy endpoint) * Freedom from alanine transaminase elevation (ALT) more than 3 folds upper reference limit "URL" or statin associated muscle symptoms associated with CK elevation more than 4 folds URL. (Safety endpoint) Secondary outcomes * Percentage of patients achieving \> 50% reduction of LDL-C and to levels below 70mg/dl at 6 weeks interval. * Percentage of LDL-C reduction at 6 weeks interval. * Reduction of high-sensitive C-reactive protein (hs-CRP) from baseline to 6 weeks interval. * Correlating statins efficacy to reduce LDL-C and likelihood to cause statins related adverse effects to genetic alleles of ABC \[ATP Binding Cassette\] types A1, G5 and G8, and of CYP450 isoenzymes. * MACE free survival at 1 year, (CV death; non fatal-MI; hospitalization for ACS, urgent unplanned revascularization and stroke).

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort

AMI Survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" (project number 2016YFC1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.

Use of High Sensitivity Cardiac Troponin In Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction

Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial

Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Abbott Vascular Medical Device Registry

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome

The objective of the study is to establish a de-scaling strategy of P2Y12 inhibitors (P2Y12 i) with a decrease in hemorrhagic events without increasing ischemic complications based on a Platelet Function Test (PFT).

Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock

This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and photoplethysmography (PPG), combined with an electrocardiography/impedance cardiography (ECG/ICG) sensor, to continuously monitor tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, stroke volume, and related metrics. Up to 20 adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction or acute decompensated heart failure and in Society for Cardiovascular Angiography and Interventions (SCAI) shock stage B, C, or D will wear the sensors on the sternum, forearm, and other locations for approximately 24 to 72 hours during standard care. Sensor data will be compared with standard-of-care hemodynamic and laboratory measurements and with the patient's clinical course to evaluate the feasibility of the device, the correlation of its measurements with established clinical parameters, and its potential to detect deterioration in SCAI shock stage earlier. No treatment decisions are made based on the study device.

SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

This is an exploratory, prospective, non-profit study (SUBDIMA) designed to investigate the prevalence and potential prognostic significance of subclinical depression in patients admitted with a first acute myocardial infarction (AMI). Subclinical depression refers to the presence of mild depressive symptoms (PHQ-9 score 5-9) that do not meet DSM-5 TR criteria for major depressive disorder but may still be clinically relevant. The primary aim is to estimate the prevalence of subclinical depression in this setting. Secondary, exploratory objectives include evaluating associations with inflammatory and metabolic biomarkers, autonomic dysfunction, cardiac function, cognitive performance, quality of life, treatment adherence, and the risk of recurrent cardiovascular events over 12 months. The study is expected to generate new descriptive data that may inform future confirmatory trials and support early, personalized approaches to integrated cardiac and mental health care.

Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors

The AMISLEEP study is nested in the "FRENCHIE" registry. The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes. Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.

iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction

In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines. The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.

The Mindray High Sensitivity Troponin-I Measurement System is an in vitro diagnostic test for the quantitative determination of high sensitivity cardiac troponin I (hs-cTnI) in human serum or plasma. The Mindray High Sensitivity Troponin-I Measurement System is to be used as an aid in the diagnosis and rule out of acute myocardial infarction (AMI).

Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)

This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.

Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study

Acute Myocardial Infarction (heart attacks) affect about 86000 people each year in the UK. Given this large number of people, it is important that health teams look at ways to ensure the best care to improve outcomes after a heart attack. In related heart conditions, the role of iron is important, but there isn't much information about what effect iron levels have on patients following a heart attack. We want to plan a large scale study to look at this, but need some early data to understand how many patients have low iron levels. This small study will take part at one NHS Trust and will test for iron levels in all patients who provide consent (we expect up to 70 patients will take part). We will also collect data from medical notes for these patients and use all of this information together to understand more about iron and to plan a larger study.

Arrhythmia Detection After MI

Patients post acute myocardial infarction (AMI) have a high risk of mortality but the use of an implantable defibrillator in the early aftermath of an AMI has not been shown to improve patients' survival. The VEST trial recently demonstrated an improved overall survival in post AMI patients with the use of a wearable defibrillator. The same improvement was not demonstrated for the risk of sudden cardiac death. Monitoring patients after AMI using an implantable cardiac monitor (ICM) may document findings that can impact patient management and eventually improve their outcomes. We are therefore conducting the AID MI trial to examine the impact of ICM on patient management in the post AMI setting.

Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.

A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy

UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention

Primary objective of the study is to evaluate the impact of adenosine pre-medication on incidence of slow flow/no-reflow after primary percutaneous coronary intervention.

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)

A Multicenter, Prospective, Randomized-Controlled Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients with Acute Myocardial Infarction. The Phase A portion of the trial will include 80 enrollments from up to 15 sites.