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Procedure

Complete Revascularization for Heart Attack & Coronary Artery Disease (COMPLETE-2 Trial)

N/A

Recruiting

Led By Shamir Mehta, MD

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI

Planned complete revascularization strategy for qualifying MI

Must not have

Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism

Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two strategies for people with heart attack or chest pain and multivessel coronary artery disease who have had successful treatment.

Who is the study for?

This trial is for heart attack patients with multivessel coronary artery disease who've had a successful PCI on the main blockage. They should have additional non-infarct-related artery narrowing and be within 72 hours post-PCI. Excluded are those with planned medical treatment only, life expectancy under 2 years, prior bypass surgery or recent non-culprit lesion PCI, among other factors.

What is being tested?

The COMPLETE-2 trial compares two strategies after a heart attack: one where further blockages are treated based on physiological assessment and another based solely on angiography images. The aim is to see which method is better for complete revascularization in patients with multiple vessel disease.

What are the potential side effects?

While specific side effects aren't listed here, procedures like PCI can cause bleeding at the catheter site, blood vessel damage, irregular heartbeats (arrhythmias), kidney problems from dye used in angiography, and rarely stroke or heart attack.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a heart attack and received a stent within the last 3 days.

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I am scheduled for a procedure to restore blood flow after my heart attack.

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I have a narrowed artery in my heart that's not caused by a previous heart attack.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart attack was caused by a non-blockage issue, like a tear in the artery or a clot.

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I have a severe blockage in my heart's arteries not responsible for my current heart issue.

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I have a health condition other than heart disease that might shorten my life to under 2 years.

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Doctors can't pinpoint the exact cause of my heart attack.

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My treatment plan includes medication for all my heart issues, not surgery.

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My heart condition affects only one area of my heart.

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I have had or am planning to have bypass surgery for my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Angiography-guided NCL PCIExperimental Treatment1 Intervention

Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Group II: Physiology-guided Non-Culprit-Lesion (NCL) PCIActive Control1 Intervention

Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.

0 / 10Eligibility criteria met