Phase
Condition
Chest Pain
Thrombosis
Atherosclerosis
Treatment
Revascularization by CABG
Revascularization by PCI
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >18 years;
LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magneticresonance within 2 months of randomization;
Prognostically important multivessel CAD (triple vessel CAD or double vessel diseaseincluding the left anterior descending (LAD) or LM). Significant coronary stenosisis 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 Asiandescent), or equivalent optical coherence tomography (OCT) measurements;
The institutional Heart Team agrees that guideline-directed medical therapy (GDMT)has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patientshospitalized 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 betitrated to maximally tolerated doses after revascularization;
Signed informed consent.
Exclusion
Exclusion Criteria:
Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasiveventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
Recent (<4 weeks) ST-elevation MI;
Concomitant severe valvular disease or other condition such as left ventricularaneurysm requiring surgical repair or replacement;
Planned major concomitant surgical procedures (LAAO and AF ablation surgicalprocedures permitted);
Prior PCI within the past 12 months (to reduce restenosis events from prior PCIscontributing to the primary outcome);
Prior cardiac surgery;
Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
Circumstances likely to lead to poor treatment adherence;
Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure,cancer) that reduces life expectancy to less than 5 years;
Current pregnancy;
Patient not amenable to both CABG or PCI according to the Heart Team;
Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
Study Design
Study Description
Connect with a study center
Medical University of Vienna
Vienna,
AustriaActive - Recruiting
Institute of Cardiology
Porto Alegre, 90610-001
BrazilActive - Recruiting
Heart Institute, Medical School of the University of Sao Paulo_INCOR
São Paulo, 05403-900
BrazilActive - Recruiting
University of Calgary; Libin Cardiovascular Institute
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
Mackenzie Health Sciences Center
Edmonton, Alberta T6G 2B7
CanadaActive - Recruiting
Fraser Health; Royal Columbian Hospital
New Westminster, British Columbia V3L3W7
CanadaActive - Recruiting
Providence Health
Vancouver, British Columbia V6Z 1Y6
CanadaActive - Recruiting
Queen Elizabeth II Hospital
Halifax, Nova Scotia B3H 2Y9
CanadaActive - Recruiting
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
London Health Sciences Center, University Hospital
London, Ontario N6A 5A5
CanadaActive - Recruiting
Southlake Regional HC
Newmarket, Ontario L3Y 2P9
CanadaActive - Recruiting
Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaActive - Recruiting
St. Michael's
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G 2N2
CanadaActive - Recruiting
Center Hospitalier Universitaire de Montreal
Montréal, Quebec , H2X OC1
CanadaActive - Recruiting
Hospital Sacre-Coeur
Montréal, Quebec H4J 1C5
CanadaActive - Recruiting
Jewish General Hospital
Montréal, Quebec H3T 1E2
CanadaActive - Recruiting
Montreal Heart Institute
Montréal, Quebec H1T 1C8
CanadaActive - Recruiting
Institut de Cardiologie Quebec (QC) - Laval
Québec, Quebec G1V 4G5
CanadaActive - Recruiting
Jilin Heart Hospital
Jilin, Changchun 130117
ChinaActive - Recruiting
Clinical Hospital Dubrava
Sušak, Zagreb 10000
CroatiaActive - Recruiting
University Hospital Dusseldorf
Düsseldorf, 40225
GermanyActive - Recruiting
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Palayam, Tamil Nadu 641037
IndiaActive - Recruiting
European Hospital, Via Portuense
Roma, RM 00149
ItalyActive - Recruiting
Instituto Mexicano del Seguro Social (IMSS)
Ciudad de México,
MexicoActive - Recruiting
Medical University of Silesia
Katowice,
PolandActive - Recruiting
Unidade Local de Saude Lisboa Ocidental (ULSLO)
Lisboa, 1350-410
PortugalActive - Recruiting
Dedinje Cardiovascular Institute
Belgrade,
SerbiaActive - Recruiting
Hospital Clinic de Barcelona (ICCV)
Barcelona, L'Eixample 08036
SpainActive - Recruiting
Hospital del Vinalopó
Alicante,
SpainActive - Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
SpainActive - Recruiting
Cedars-Sinai
Los Angeles, California 90048
United StatesActive - Recruiting
UofL Health, Inc
Louisville, Kentucky 40202
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
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