Comparing immediate versus staged heart surgery for patients with severe heart attacks and multiple blocked arteries

Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

This study is testing whether doing all heart surgery at once or in stages is better for people who have had a severe heart attack and have multiple blocked arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 840 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05967663 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of two different strategies for treating patients with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary disease. It compares immediate complete revascularization with staged revascularization, guided by fractional flow reserve (FFR) assessments. The study is prospective, multicenter, randomized, and controlled, aiming to determine which approach yields better outcomes for patients. Participants will undergo successful primary percutaneous coronary intervention (PCI) of the culprit lesion before being assigned to one of the two treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced a STEMI and have multivessel coronary disease requiring intervention.

Not a fit: Patients who have received thrombolytic therapy, are in cardiac shock, or have severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for patients experiencing severe heart attacks, potentially enhancing recovery and reducing complications.

How similar studies have performed: Previous studies have shown promising results with similar approaches in managing multivessel coronary disease, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
3. Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented
4. Sign an informed consent form before participating in the study

Exclusion Criteria:

1. Received thrombolytic therapy
2. Cardiac shock or SBP\<90mmHg;
3. History of old myocardial infarction;
4. Left main artery lesion, non infarct related vessels are CTO lesions;
5. PCI in the previous 30 days or Previous CABG
6. Patients who cannot give informed consent or have a life expectancy of less than 1 year
7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia
8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
9. Not suitable for clinical research:

   1. Currently participating in another study that may affect the primary endpoint
   2. Pregnant and lactating women;
   3. Known allergy to drugs that may be used in the study;
   4. Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

Where this trial is running

Shanghai

• Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jun Pu, MD, PhD — RenJi Hospital
• Study coordinator: Jun Pu, MD, PhD

Conditions ST Elevation Myocardial Infarction; STEMI; Coronary Artery Disease; Coronary Syndrome