RECRUITING

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

Conditions

Coronary Artery Disease Heart Failure Systolic Left ventricular dysfunction CABG PCI MACCE

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Study Overview

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Description

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

Quick Facts

Study Start:2023-06-22

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05427370

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 Criteria	Exclusion Criteria
1. Age \>18 years; 2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization; 3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (\<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements; 4. The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization.	1. Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization; 2. Recent (\<4 weeks) ST-elevation MI; 3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement; 4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted); 5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome); 6. Prior cardiac surgery; 7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy; 8. Circumstances likely to lead to poor treatment adherence; 9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years; 10. Current pregnancy; 11. Patient not amenable to both CABG or PCI according to the Heart Team; 12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome; 13. Failure to provide informed consent.

Inclusion Criteria

Exclusion Criteria

1. Age \>18 years;
2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (\<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
4. The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization.

1. Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
2. Recent (\<4 weeks) ST-elevation MI;
3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
6. Prior cardiac surgery;
7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
8. Circumstances likely to lead to poor treatment adherence;
9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
10. Current pregnancy;
11. Patient not amenable to both CABG or PCI according to the Heart Team;
12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome;
13. Failure to provide informed consent.

Contacts and Locations

Study Contact

Stephen Fremes, MD,MSc,FRCSC

CONTACT

416-480-6100

stephen.fremes@sunnybrook.ca

Reena Karkhanis, MBBS,DA,MSc

CONTACT

416-480-6100

reena.karkhanis@sunnybrook.ca

Principal Investigator

Stephen Fremes, MD,MSc,FRCSC

PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center, Toronto, Canada

Mario Gaudino, MD,PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University, USA

Jean L Rouleau, MD,PhD

PRINCIPAL_INVESTIGATOR

Montreal Heart Institute, QC Canada

Guillaume Maquis-Gravel, MD,MSc

PRINCIPAL_INVESTIGATOR

Montreal Heart Institute, QC Canada

Study Locations (Sites)

Cedars-Sinai

Los Angeles, California, 90048

United States

UofL Health, Inc

Louisville, Kentucky, 40202

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Sunnybrook Health Sciences Centre

Stephen Fremes, MD,MSc,FRCSC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Center, Toronto, Canada
Mario Gaudino, MD,PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University, USA
Jean L Rouleau, MD,PhD, PRINCIPAL_INVESTIGATOR, Montreal Heart Institute, QC Canada
Guillaume Maquis-Gravel, MD,MSc, PRINCIPAL_INVESTIGATOR, Montreal Heart Institute, QC Canada

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 Date2029-12

Study Record Updates

Study Start Date2023-06-22

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Left ventricular dysfunction
CABG
PCI
MACCE

Additional Relevant MeSH Terms

Coronary Artery Disease
Heart Failure Systolic