Improving heart blood flow after heart attacks

A Comparative Study of 60 MHz HD-IVUS, OCT, and Conventional Angiography to Guide Reperfusion Therapy for Improving Myocardial Microcirculation Dysfunction After Acute Anterior Myocardial Infarction

This study is testing different imaging techniques to see which one helps improve blood flow in the heart after a heart attack in patients with a specific type of heart condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT06154395 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of different imaging-guided approaches for coronary revascularization in patients experiencing anterior wall ST-segment elevation myocardial infarction (STEMI). Ninety patients will be randomized into three groups: one receiving optical coherence tomography (OCT) guidance, another receiving 60 MHz high-definition intravascular ultrasound (HD-IVUS) guidance, and a control group receiving standard angiography guidance. The study aims to assess myocardial microcirculation improvement post-procedure using TIMI myocardial perfusion frame count (TMPFC) and cardiac MRI. The trial is designed to enhance treatment outcomes for patients undergoing primary percutaneous coronary intervention (PCI).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced anterior wall STEMI and are scheduled for primary PCI within 6 hours of symptom onset.

Not a fit: Patients with a history of coronary artery bypass grafting (CABG) or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved myocardial perfusion and better recovery outcomes for patients after a heart attack.

How similar studies have performed: Other studies have shown promising results with imaging-guided interventions in coronary revascularization, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Clinical Inclusion Criteria:

1. Subjects aged ≥18 years;
2. Initial diagnosis of anterior wall ST-segment elevation myocardial infarction, with symptoms occurring within 6 hours, and undergoing primarypercutaneous coronary intervention (PCI);
3. Subjects (or legal representatives) who understand the study requirements and treatment procedures and provide signed informed consent.

Imaging Inclusion Criteria (Visual Estimation):

1. Target lesion is the culprit lesion, located in the native coronary artery, with a visually estimated reference vessel diameter (RVD) between 2.25 mm and 4.0 mm;
2. Culprit segment of the infarct-related artery (IRA) is located between the origin of the left anterior descending (LAD) artery and the emergence of the second diagonal branch (D2);
3. After pre-treatment , the degree of stenosis in the LAD is ≤90%, and TIMI flow is grade 3.

Exclusion Criteria:

Clinical Exclusion Criteria:

1. History of coronary artery bypass grafting (CABG);
2. Known history of myocardial infarction or PCI;
3. Previous thrombolytic therapy before PCI;
4. Severe liver or kidney dysfunction, severe valvular heart disease, chronic obstructive pulmonary disease, etc.;
5. Contraindications to magnetic resonance imaging;
6. Allergy to gadolinium contrast agents and/or accompanying medications for devices or procedures (e.g., any component of drug-eluting stents, all P2Y12 inhibitors, or aspirin);
7. Expected lifespan of the subject less than 12 months;
8. Pregnant or lactating females;
9. Other subjects deemed unsuitable for participation in the study by the investigator.

Imaging Exclusion Criteria (Visual Estimation):

1. Presence of lesions requiring intervention other than the target lesion at baseline surgery;
2. No protected left main coronary artery disease (visual estimate of stenosis \>50%);
3. Diffuse severe calcification (\>20 mm) or chronic total occlusion in the major coronary vessels (LCX, RCA);
4. Severe coronary artery tortuosity (\>45°) or calcification (\>270°), or other conditions that may interfere with the use of intravascular imaging.

Where this trial is running

Harbin, Heilongjiang

• The 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Principal investigator: Bo Yu, M.D.; Ph.D. — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Xingtao Huang, MD

Conditions Intravascular Imaging and Microvascular Obstruction