The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-000257
NCT ID: NCT05427370
Sponsor Protocol Number: 22-02-610-380
About this study
The purpose of this study 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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
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. Failure to provide informed consent.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/9/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available