RecruitingNot applicable

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

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares heart bypass surgery (CABG) with a procedure to open blocked heart arteries (PCI). It is for adults with major blockages in several heart arteries or the main left heart artery, and a heart that pumps weakly. The study checks which treatment lowers the risk of death, stroke, heart attack, urgent repeat treatment, or a hospital stay for heart failure over about 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • A heart scan within the past 2 months shows that your heart pumps out 40% or less of its blood with each beat.
  • You have major blockages in three heart arteries, in two including the front heart artery, or in the main left heart artery. Heart tests must show that the blockages meet the study’s limits.
  • Your heart care team agrees that both bypass surgery and PCI are suitable for you, and treatment is not an emergency.
  • You have started recommended heart medicines at least 1 month ago. If you are in the hospital with newly found heart weakness and need treatment before going home, medicines should start before study assignment when possible and be adjusted afterward.
  • You sign a form agreeing to take part after learning about the study.

Who can't join

  • Within 48 hours before study assignment, worsening heart failure required medicines to support heart pumping, breathing support, or a heart pump device.
  • You had a STEMI, a type of heart attack, less than 4 weeks ago.
  • You have severe heart valve disease or another problem needing heart surgery, or another major surgery is planned at the same time. Certain procedures for an irregular heartbeat are allowed.
  • You had PCI in the past 12 months or any heart surgery before.
  • Your bleeding risk is too high to take two medicines that help prevent blood clots, or your situation makes it hard to follow treatment.
  • You have a serious illness, such as kidney disease needing dialysis, liver or breathing failure, or cancer, that is expected to shorten your life to less than 5 years.
  • You are pregnant, or your heart care team says that either bypass surgery or PCI is not suitable for you.
  • You have Takotsubo cardiomyopathy, also called broken heart syndrome.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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; 5. Signed informed consent. Exclusion Criteria: 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.

Study sites (6)

CA

  • Cedars-Sinai · Los Angeles, CA 90048Dominic Emerson · Study contactRaj Makkar · Sub-investigatorMamoo Nakamura · Sub-investigatorMichael Bowdish · Sub-investigatorMore trials in Los Angeles

CT

  • Yale University · New Haven, CT 06510Marc Pelletier · Study contactKathryn Clark · Sub-investigatorMore trials in New Haven

KY

  • UofL Health, Inc · Louisville, KY 40202Naresh Solanki · Study contactRavi Sharma · Sub-investigatorRohan Samson · Sub-investigatorSiddarth Pahwa · Sub-investigatorMore trials in Louisville

MD

  • John Hopkins Hospital · Baltimore, MD 21205Jennifer Lawton · Study contactJon Resar · Sub-investigatorMore trials in Baltimore

MN

OH

  • University Hospitals Cleveland Medical Center · Cleveland, OH 44106Rakesh Arora · Study contactYasir Abu-Omar · Sub-investigatorAnene Ukaigwe · Sub-investigatorEiran Gorodeski · Sub-investigatorMore trials in Cleveland