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NCT05701358 | Recruiting | Acute Myocardial Infarction

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

Population Health Research Institute

Brief Summary:

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.

Condition or disease

Acute Myocardial Infarction

Coronary Artery Disease

Intervention/treatment

Physiology-guided NCL PCI

Angiography-guided NCL PCI

Phase

Not Applicable

Detailed Description:

COMPLETE-2 STUDY OBJECTIVES To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR). To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.}}

Study Type : Interventional
Estimated Enrollment : 5100 participants
Masking : Single
Primary Purpose : Treatment
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
Actual Study Start Date : June 22, 2023
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2028
Arm Intervention/treatment

Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI

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.

Procedure: Physiology-guided NCL PCI

Other: Angiography-guided NCL PCI

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

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

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, California

UCLA

The Angels, California, United States, 90095

Recruiting

United States, Kansas

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States, 67226

Recruiting

United States, Maryland

The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21205

Recruiting

United States, New York

Bassett Medical Center

Cooperstown, New York, United States, 13326

Recruiting

Canada,

University of Calgary - Foothills Medical Centre

Calgary, Canada,

Recruiting

Canada,

University of Alberta Hospital, Mazankowski Heart

Edmonton, Canada,

Recruiting

Canada,

Hamilton Health Sciences

Hamilton, Canada,

Recruiting

Canada,

St. Mary's General Hospital

Kitchener, Canada,

Recruiting

Canada,

Hospital Center of the University of Montreal

Montréal, Canada,

Recruiting

Canada,

Sacre-Coeur Hospital of Montreal

Montréal, Canada,

Recruiting

Canada,

Southlake Regional Health Centre

Newmarket, Canada,

Recruiting

Canada,

University of Ottawa Heart Institute

Ottawa, Canada,

Recruiting

Canada,

Royal University Hospital

Saskatoon, Canada,

Recruiting

Canada,

Newfoundland and Labrador Health Services

St. John's, Canada,

Recruiting

Canada,

St. Michael's Hospital (Unity Health Toronto)

Toronto, Canada,

Recruiting

Canada,

Sunnybrook Health Sciences Centre

Toronto, Canada,

Recruiting

Denmark,

Aalborg University Hospital

Aalborg, Denmark,

Recruiting

Denmark,

Rigshospitalet - Copenhagen University Hospital

Copenhagen, Denmark,

Recruiting

Germany,

University Heart & Vascular Center Hamburg

Hamburg, Germany,

Recruiting

Italy,

Ferrara University Hospital

Ferrara, Italy,

Recruiting

Italy,

USL-IRCCS company of Reggio Emilia, Reggio

Reggio Emilia, Italy,

Recruiting

Italy,

Sant Andrea Hospital - Sapienza University

Rome, Italy,

Recruiting

Sweden,

Karolinska University Hospital

Huddinge, Sweden,

Recruiting

Sweden,

Skane University Hospital

Lund, Sweden,

Recruiting

Sweden,

Danderyd Hospital

Stockholm, Sweden,

Recruiting

Sweden,

Umeå University Hospital

Umeå, Sweden,

Recruiting

United Kingdom,

Kettering General Hospital

Kettering, United Kingdom,

Recruiting

United Kingdom,

Sheffield Teaching Hospitals

Sheffield, United Kingdom,