What is this study studying for acute myocardial infarction and multivessel coronary artery disease?

This study is comparing two strategies for treating blockages in multiple coronary arteries after an acute heart attack. Researchers want to find out if physiology-guided complete revascularization is as effective and safe as angiography-guided revascularization. The Population Health Research Institute is leading this research to improve treatment decisions for patients with heart attacks and complex artery disease.

Who may be eligible for this acute myocardial infarction clinical trial?

Adults aged 18 years or older who have had a STEMI or type 1 NSTEMI heart attack and a successful PCI on the culprit lesion within 72 hours may be eligible. Participants must have at least one additional coronary artery narrowing suitable for PCI and plan to have complete revascularization. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this acute myocardial infarction clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study. Participants should plan accordingly for any such costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05701358

Comparing Physiology-Guided and Angiography-Guided Complete Revascularization in Patients with Acute Myocardial Infarction and Multivessel Coronary Artery Disease

Led by Population Health Research Institute · Updated on 2025-06-19

5100

Participants Needed

113

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

CONDITIONS

Brief Title

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients presenting with STEMI or type 1 NSTEMI within 72 hours of successful culprit-lesion PCI
Residual coronary artery disease with at least one additional non-infarct-related coronary artery stenosis amenable to PCI
The stenosis must be at least 50% diameter narrowing by visual estimation
The stenosis must be in a vessel at least 2.5 mm in diameter
Planned complete revascularization for qualifying myocardial infarction

You will not qualify if you...

Planned or prior coronary artery bypass graft (CABG) surgery
Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiography, ECG, or regional wall motion abnormalities
Prior PCI of a non-culprit lesion in a different vessel within 45 days of randomization
Planned medical treatment of all qualifying non-culprit lesions without PCI
Severe non-culprit lesion stenosis with reduced epicardial flow (TIMI flow 62; 2) or greater than 90% visual diameter stenosis
Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion
The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
Baseline STEMI or NSTEMI due to a suspected non-atherothrombotic cause such as type 2 MI, spontaneous coronary artery dissection, or embolism
Non-cardiovascular conditions with expected life expectancy less than 2 years
Any medical, geographic, or social factor preventing participation or 5-year follow-up

Research Team

COMPLETE-2 Project Office

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Comparing Physiology-Guided and Angiography-Guided Complete Revascularization in Patients with Acute Myocardial Infarction and Multivessel Coronary Artery Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria