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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study completion, a minimum of 2 years

Awards & highlights

COMPLETE-2 Trial 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.Check my eligibility

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.See study design

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.

COMPLETE-2 Trial 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.

COMPLETE-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion, a minimum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion, a minimum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, a minimum of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR

Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.

Secondary outcome measures

Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Time to first occurrence of the composite of CV death or new MI.

COMPLETE-2 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

674,812 Total Patients Enrolled

Shamir Mehta, MDPrincipal InvestigatorPopulation Health Research Institute

1 Previous Clinical Trials

200 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this research endeavor?

"Affirmative. Clinicaltrials.gov hosts data that confirms this clinical trial is currently enrolling participants; it was first advertised on 22 June 2023 and last updated on 22 August 2023. 5100 patients are needed at single location for the study to be completed."

Answered by AI

What is the total number of individuals participating in this research endeavor?

"Yes, according to the data available on clinicaltrials.gov this clinical trial is actively enrolling participants. It was initially posted in June of 2023 and has been updated as recently as August 22nd of the same year. A total 5100 individuals will be recruited through a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701358.

All > Coronary Artery Disease