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

Description

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Conditions

Acute Myocardial Infarction, Coronary Artery Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

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

Condition
Acute Myocardial Infarction
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Wichita

Cardiovascular Research Institute of Kansas, Wichita, Kansas, United States, 67226

Baltimore

The Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 21205

Cooperstown

Bassett Medical Center, Cooperstown, New York, United States, 13326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
  • 2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
  • 1. Amenable to successful treatment with PCI
  • 2. At least 50% diameter stenosis by visual estimation
  • 3. At least 2.5 mm in diameter
  • 3. Planned complete revascularization strategy for qualifying MI
  • 1. Planned or prior coronary artery bypass graft (CABG) surgery
  • 2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
  • 3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
  • 4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  • 5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
  • 6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
  • 7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  • 8. 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
  • 9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years
  • 10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Population Health Research Institute,

Shamir Mehta, MD, PRINCIPAL_INVESTIGATOR, Population Health Research Institute

Study Record Dates

2028-06