Clinical Research Directory

Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention

This study aims to evaluate myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Although primary PCI successfully restores blood flow in the blocked coronary artery, some patients continue to have impaired blood flow within the small vessels of the heart muscle, a condition known as microvascular obstruction (MVO). This complication may be associated with greater myocardial injury and poorer clinical outcomes. The study will investigate whether artificial intelligence (AI)-derived electrocardiographic (ECG) features, coronary angiographic parameters, and cardiac magnetic resonance (CMR) findings can provide complementary information about myocardial reperfusion. Patients undergoing primary PCI will be assessed using ECG and angiographic findings, while CMR will be used to evaluate myocardial injury and microvascular obstruction. The main objective is to determine whether combining AI-derived ECG features and angiographic parameters can improve the prediction of CMR-detected microvascular obstruction after primary PCI. The findings may help identify patients at increased risk of impaired myocardial reperfusion and support future risk assessment strategies following STEMI.

For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.

Brief Summary The Purpose of the Study : The purpose of this study is to find a safe and reliable "one-stop" solution for treating heart attack patients who have multiple blocked arteries. Currently, doctors face a dilemma: Testing these other blockages during the heart attack procedure is often unreliable. The most accurate method requires asking the patient to return 30 days later for a second invasive procedure, which is a significant burden. The Study's Hypothesis : We are testing a new tool called UFR, which uses ultrasound images to measure blockages. Our hypothesis (or "educated guess") is that this new UFR tool is not affected by the body's stress during a heart attack and can provide a true, reliable measurement right away. The Question the Study is Trying to Answer ： The main question this study is trying to answer is: Can the new "one-stop" UFR tool, used during the initial heart attack procedure, accurately predict which blockages are truly serious... thereby eliminating the need for patients to return for a second procedure 30 days later? Researchers will also follow 200 patients for one year, using advanced scans (like UFR, standard tests, and MRI), to better understand how the heart and arteries heal and change over time.

Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations. Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.