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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

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 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

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.

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
161 Previous Clinical Trials
707,034 Total Patients Enrolled
Shamir Mehta, MDPrincipal InvestigatorPopulation Health Research Institute
1 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Angiography-guided NCL PCI (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05701358 — N/A
Heart Attack Research Study Groups: Physiology-guided Non-Culprit-Lesion (NCL) PCI, Angiography-guided NCL PCI
Heart Attack Clinical Trial 2023: Angiography-guided NCL PCI Highlights & Side Effects. Trial Name: NCT05701358 — N/A
Angiography-guided NCL PCI (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701358 — N/A
~3400 spots leftby Jun 2028
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