Phase
Condition
Heart Disease
Circulation Disorders
Chest Pain
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,
AustriaSite Not Available
Medical University of Vienna
Vienna 2761369,
AustriaActive - Recruiting
Institute of Cardiology
Porto Alegre, 90610-001
BrazilSite Not Available
Heart Institute, Medical School of the University of Sao Paulo_INCOR
São Paulo, 05403-900
BrazilSite Not Available
Heart Institute, Medical School of the University of Sao Paulo_INCOR
São Paulo 3448439, 05403-900
BrazilActive - Recruiting
University of Calgary; Libin Cardiovascular Institute
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Mackenzie Health Sciences Center
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
University of Calgary; Libin Cardiovascular Institute
Calgary 5913490, Alberta 5883102 T2N 4Z6
CanadaActive - Recruiting
Mackenzie Health Sciences Center
Edmonton 5946768, Alberta 5883102 T6G 2B7
CanadaActive - Recruiting
Fraser Health; Royal Columbian Hospital
New Westminster, British Columbia V3L3W7
CanadaSite Not Available
Providence Health
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Fraser Health; Royal Columbian Hospital
New Westminster 6087844, British Columbia 5909050 V3L3W7
CanadaSite Not Available
Providence Health
Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
CanadaActive - Recruiting
Queen Elizabeth II Hospital
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Queen Elizabeth II Hospital
Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
CanadaActive - Recruiting
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
London Health Sciences Center, University Hospital
London, Ontario N6A 5A5
CanadaSite Not Available
Southlake Regional HC
Newmarket, Ontario L3Y 2P9
CanadaSite Not Available
Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
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
CanadaSite Not Available
Hamilton General Hospital
Hamilton 5969782, Ontario 6093943 L8L 2X2
CanadaActive - Recruiting
London Health Sciences Center, University Hospital
London 6058560, Ontario 6093943 N6A 5A5
CanadaActive - Recruiting
Southlake Regional HC
Newmarket 6087701, Ontario 6093943 L3Y 2P9
CanadaActive - Recruiting
Ottawa Heart Institute
Ottawa 6094817, Ontario 6093943 K1Y 4W7
CanadaActive - Recruiting
St. Michael's
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaActive - Recruiting
Sunnybrook Health Sciences Center
Toronto 6167865, Ontario 6093943 M4N 3M5
CanadaActive - Recruiting
Toronto General Hospital
Toronto 6167865, Ontario 6093943 M5G 2N2
CanadaActive - Recruiting
Center Hospitalier Universitaire de Montreal
Montréal, Quebec , H2X OC1
CanadaSite Not Available
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
CanadaSite Not Available
Center Hospitalier Universitaire de Montreal
Montreal 6077243, Quebec 6115047 , H2X OC1
CanadaActive - Recruiting
Hospital Sacre-Coeur
Montreal 6077243, Quebec 6115047 H4J 1C5
CanadaActive - Recruiting
Montreal Heart Institute
Montreal 6077243, Quebec 6115047 H1T 1C8
CanadaActive - Recruiting
Institut de Cardiologie Quebec (QC) - Laval
Québec 6325494, Quebec 6115047 G1V 4G5
CanadaActive - Recruiting
Jilin Heart Hospital
Jilin, Changchun 130117
ChinaSite Not Available
Jilin Heart Hospital
Jilin 2036502, Changchun 130117
ChinaActive - Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200031
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 1796236, 200031
ChinaActive - Recruiting
Clinical Hospital Dubrava
Sušak, Zagreb 10000
CroatiaActive - Recruiting
University Hospital Dusseldorf
Düsseldorf, 40225
GermanySite Not Available
University Hospital Dusseldorf
Düsseldorf 2934246, 40225
GermanyActive - Recruiting
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Palayam, Tamil Nadu 1255053 641037
IndiaActive - Recruiting
European Hospital, Via Portuense
Roma, RM 00149
ItalySite Not Available
European Hospital, Via Portuense
Roma 8957247, RM 00149
ItalyActive - Recruiting
Instituto Mexicano del Seguro Social (IMSS)
Ciudad de México,
MexicoSite Not Available
Instituto Mexicano del Seguro Social (IMSS)
Mexico City 3530597,
MexicoActive - Recruiting
Medical University of Silesia
Katowice,
PolandSite Not Available
Medical University of Silesia
Katowice 3096472,
PolandSite Not Available
Unidade Local de Saude Lisboa Ocidental (ULSLO)
Lisboa, 1350-410
PortugalSite Not Available
Unidade Local de Saude Lisboa Ocidental (ULSLO)
Lisbon 2267057, 1350-410
PortugalActive - Recruiting
Centro Hospitalar e Universitário Sao João
Porto 2735943, 4200-319
PortugalActive - Recruiting
Dedinje Cardiovascular Institute
Belgrade,
SerbiaSite Not Available
Dedinje Cardiovascular Institute
Belgrade 792680,
SerbiaActive - Recruiting
Hospital Clinic de Barcelona (ICCV)
Barcelona, L'Eixample 08036
SpainSite Not Available
Hospital Clinic de Barcelona (ICCV)
Barcelona 3128760, L'Eixample 08036
SpainActive - Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar 2518294, Murcia 2513413 30120
SpainActive - Recruiting
Hospital del Vinalopó
Alicante,
SpainSite Not Available
Hospital del Vinalopó
Alicante 2521978,
SpainActive - Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
SpainSite Not Available
Hospital Universitario de Navarra
Pamplona 3114472, 31008
SpainActive - Recruiting
Cedars-Sinai
Los Angeles, California 90048
United StatesSite Not Available
Cedars-Sinai
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
Yale University
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
UofL Health, Inc
Louisville, Kentucky 40202
United StatesSite Not Available
UofL Health, Inc
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
John Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21205
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
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