Comparing immediate versus staged heart surgery for patients with severe heart attacks and multiple blocked arteries
Official title: Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
Run by RenJi Hospital · NCT05967663 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 840 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | November 11, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2028 |
| Registry record updated | December 4, 2023 |
| Trial ID | NCT05967663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have experienced a STEMI and have multivessel coronary disease requiring intervention.
✕Probably not a fit
Patients who have received thrombolytic therapy, are in cardiac shock, or have severe comorbid conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar approaches in managing multivessel coronary disease, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: pujun310@hotmail.com
- Phone: 86-21-68383477
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.