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RECRUITING
NCT05427370
NA

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF). The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization. The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.

Official title: The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

754

Start Date

2023-06-22

Completion Date

2029-12

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

PROCEDURE

Revascularization by PCI

Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.

PROCEDURE

Revascularization by CABG

The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.

Locations (40)

Cedars-Sinai

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

UofL Health, Inc

Louisville, Kentucky, United States

John Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Medical University of Vienna

Vienna, Austria

Heart Institute, Medical School of the University of Sao Paulo_INCOR

São Paulo, Brazil

University of Calgary; Libin Cardiovascular Institute

Calgary, Alberta, Canada

Mackenzie Health Sciences Center

Edmonton, Alberta, Canada

Fraser Health; Royal Columbian Hospital

New Westminster, British Columbia, Canada

Providence Health

Vancouver, British Columbia, Canada

Queen Elizabeth II Hospital

Halifax, Nova Scotia, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

London Health Sciences Center, University Hospital

London, Ontario, Canada

Southlake Regional HC

Newmarket, Ontario, Canada

Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

St. Michael's

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Center Hospitalier Universitaire de Montreal

Montreal, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Hospital Sacre-Coeur

Montreal, Quebec, Canada

Institut de Cardiologie Quebec (QC) - Laval

Québec, Quebec, Canada

Jilin Heart Hospital

Jilin, Changchun, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Clinical Hospital Dubrava

Sušak, Zagreb, Croatia

Al Nas Hospital

Cairo, Qalyubia Governorate, Egypt

University Hospital Dusseldorf

Düsseldorf, Germany

G Kuppuswamy Naidu Memorial Hospital (GKNM)

Palayam, Tamil Nadu, India

European Hospital, Via Portuense

Roma, RM, Italy

Instituto Mexicano del Seguro Social (IMSS)

Mexico City, Mexico

Medical University of Silesia

Katowice, Poland

Unidade Local de Saude Lisboa Ocidental (ULSLO)

Lisbon, Portugal

Centro Hospitalar e Universitário Sao João

Porto, Portugal

Dedinje Cardiovascular Institute

Belgrade, Serbia

Hospital Clinic de Barcelona (ICCV)

Barcelona, L'Eixample, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital del Vinalopó

Alicante, Spain

Hospital Universitario de Navarra

Pamplona, Spain