Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

Launched by CHINESE PLA GENERAL HOSPITAL · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how advanced imaging techniques can help identify high-risk coronary plaques in patients with coronary artery disease, particularly those experiencing acute coronary syndromes like heart attacks or unstable angina. The study will involve around 500 participants across 11 hospitals, and it aims to see if certain types of plaques in the arteries are more likely to cause serious heart problems. By using special imaging methods after a procedure called percutaneous coronary intervention (PCI), researchers will categorize these plaques as either high-risk or not, and follow up with patients to monitor their health.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with acute coronary syndrome, meaning they have had symptoms like chest pain or have undergone emergency treatment for heart issues. Participants should also have at least one artery with a narrowing that is moderate but not severe enough to require immediate surgery. Those who are in critical condition, have severe kidney problems, or are involved in other clinical studies will not be able to join. If someone decides to participate, they can expect to undergo specific imaging tests to help doctors better understand their heart condition and improve future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Inclusion criteria for the clinical study:
• • 1. Aged ≥18 years at enrollment, male or female;
• • 2. Meets the diagnosis of acute coronary syndrome, including acute myocardial infarction and unstable angina. Acute myocardial infarction includes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (non-STEMI). STEMI is defined as chest pain lasting at least 30 minutes, arriving at the hospital within 12 hours from the onset of symptoms, changes in the 12-lead ECG (ST-segment elevation \>0.1 mV in ≥2 consecutive leads or new left bundle branch block), and elevated cardiac biomarkers (troponin T/I). Non-STEMI is defined as ischemic symptoms without ST-segment elevation on ECG, accompanied by elevated cardiac biomarkers. Unstable angina is defined as chest pain lasting 5-30 minutes at rest, or worsening of exertional angina, and accompanied by one of the following: transient ST-segment depression or elevation; coronary angiography showing luminal narrowing ≥90% or plaque rupture or thrombotic lesions.
• • 3. Planned to undergo coronary angiography and PCI treatment;
• • 4. Hemodynamically stable and able to tolerate repeated intracoronary administration of nitroglycerin;
• • 5. Capable of understanding the requirements of this study, willing to participate in the study, and have signed an informed consent form.
• * Imaging inclusion criteria:
• • 1. Coronary angiography clearly shows that the patient has at least one non-culprit lesion with a visual assessment of diameter stenosis between 40-70%, and the operator believes that interventional treatment intervention is not temporarily necessary;
• • 2. The site of the non-culprit lesion has not previously had a stent implanted.
• Exclusion Criteria:
• * Exclusion criteria for the clinical study:
• • 1. Cardiogenic shock or hemodynamic instability;
• • 2. History of coronary artery bypass grafting (CABG), or planned CABG;
• • 3. Severe renal impairment (glomerular filtration rate \<30ml/min/1.73m²);
• • 4. Life expectancy of less than 2 years;
• • 5. Currently participating in other ongoing investigative device or drug studies that have not yet reached their primary endpoints.
• * Imaging exclusion criteria:
• • The anatomical structure of the non-culprit lesion is not suitable for intravascular imaging catheter imaging (lesions at the left main trunk or right coronary artery ostium, severe calcification, chronic total occlusion, etc.).