RECRUITING

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

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Conditions

Acute Myocardial InfarctionCoronary Artery DiseaseNSTEMISTEMImulti-vessel diseaseoptical coherence tomographyFFRRFRpercutaneous coronary intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-22
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701358

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
  2. 2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
  3. 1. Amenable to successful treatment with PCI
  4. 2. At least 50% diameter stenosis by visual estimation
  5. 3. At least 2.5 mm in diameter
  6. 3. Planned complete revascularization strategy for qualifying MI
  1. 1. Planned or prior coronary artery bypass graft (CABG) surgery
  2. 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. 3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
  4. 4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  5. 5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
  6. 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. 7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  8. 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. 9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years
  10. 10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Contacts and Locations

Study Contact

COMPLETE-2 Project Office
CONTACT
(905) 521-2100
complete-2@phri.ca

Principal Investigator

Shamir Mehta, MD
PRINCIPAL_INVESTIGATOR
Population Health Research Institute

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
Bassett Medical Center
Cooperstown, New York, 13326
United States

Collaborators and Investigators

Sponsor: Population Health Research Institute

  • Shamir Mehta, MD, PRINCIPAL_INVESTIGATOR, Population Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-06-22
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • NSTEMI
  • STEMI
  • multi-vessel disease
  • optical coherence tomography
  • FFR
  • RFR
  • percutaneous coronary intervention

Additional Relevant MeSH Terms

  • Acute Myocardial Infarction
  • Coronary Artery Disease