Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention | Experimental |
| |
| Coronary-Artery Bypass Grafting | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| State-of-the-Art Percutaneous Coronary Intervention | Procedure | supported by intracoronary imaging (e.g., intravascular ultrasound [IVUS] or optical coherence tomography [OCT]), intracoronary physiology (e.g., fractional flow reserve [FFR] or instantaneous wave-free ratio [iFR]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy [GDMT] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications [e.g., a sodium-glucose cotransporter [SGLT]-2 inhibitors or Glucagon-like peptide-1 [GLP-1] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)](streamdown:incomplete-link) |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of major adverse cardiac or cerebrovascular events | Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of death from any cause | 5 years | |
| The event rate of myocardial infarction | 5 years | |
| The event rate of repeat revascularization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
2) Screening failed before any interventional factor is involved.
3) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-hee Ham, Project manager | Contact | 82-2-3010-4728 | cvcrc5@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seung-jung Park, MD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto VA Medical Center | Recruiting | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| standard CABG | Procedure | Coronary-Artery Bypass Grafting |
|
| 5 years |
| The event rate of stroke | 5 years |
| The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes | 5 years |
| The event rate of myocardial infarction | any, spontaneous or procedural | 5 years |
| The event rate of composite of death or myocardial infarction | 5 years |
| The event rate of composite of death, myocardial infarction, stroke or repeat revascularization | 5 years |
| The event rate of stent thrombosis | by an Academic Research Consortium (ARC) definition | 5 years |
| The event rate of symptomatic graft occlusion or stenosis | 5 years |
| The event rate of bleeding complications | BARC (Bleeding Academic Research Consortium) criteria | 5 years |
| The event rate of periprocedural major adverse events | Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (>48 hours), post-pericardiotomy syndrome, etc. | 5 years |
| Length of hospital stay | 7 days |
| The event rate of rehospitalization | any, cardiac, or noncardiac causes | 7 days |
| The change of functional class | Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina. | 1, 6, 12, 18, 24, 36, 60 months |
| The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ] | The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status. | 1, 12, 24, 36, 60 months |
| The change of angina-related quality of life index by the EQ-5D | EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life. | 1, 12, 24, 36, 60 months |
| The number of anti-anginal medications used | 1, 6, 12, 18, 24, 36, 60 months |
| Total healthcare costs and cost-effectiveness assessed using total medical expenditures and incremental cost-effectiveness ratio (ICER) | Total medical cost will be calculated using predefined cost components related to the index revascularization procedure (PCI or CABG) and subsequent healthcare utilization. The list of cost items includes (but is not limited to): diagnostic catheters, guide catheters, guidewires, balloons, stents, adjunctive devices (e.g., rotablation system, intravascular lithotripsy), professional procedure fees, CABG-related graft categories, hospitalization cost per day (Intensive care unit and ward), and non-invasive cardiac tests. Total costs will be aggregated for each participant and compared between study groups at each scheduled time point. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), calculated as the difference in total costs divided by the difference in clinical effectiveness between the study groups. | 1, 6, 12, 18, 24, 36, 60 months |
| Victorian Heart Institute | Recruiting | Clayton | Australia |
|
| Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS) | Recruiting | Beijing | China |
|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hanzhou | China |
|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Mody Harvard Cardiac Institute | Recruiting | Bathinda | India |
|
| Medanta - The Medicity | Recruiting | Gurugram | India |
|
| Fortis Escorts Heart Institute | Recruiting | New Delhi | India |
|
| Tsuchiura Kyodo Hospital | Recruiting | Tsuchiura | Japan |
|
| Pauls Stradins Clinical University Hospital | Recruiting | Riga | Latvia |
|
| Vilnius University Hospital Santaros Klinikos | Recruiting | Vilnius | Lithuania |
|
| Sarawak Heart Centre | Recruiting | Kota Samarahan | Malaysia |
|
| University Clinical Center of Serbia | Recruiting | Belgrade | Serbia |
|
| National Heart Centre Singapore (NHCS) | Recruiting | Singapore | Singapore |
|
| Bucheon Sejong Hospital | Recruiting | Bucheon-si | South Korea |
|
| Daegu Catholic University Medical Center | Not yet recruiting | Daegu | South Korea |
|
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Yeungnam University Medical Center | Not yet recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Konyang University Hospital | Withdrawn | Daejeon | South Korea |
| Gangneung Asan Hospital | Not yet recruiting | Gangneung | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
|
| National Health Insurance Service Ilsan Hospital | Recruiting | Ilsan | South Korea |
|
| Gachon University Gil Hospital | Not yet recruiting | Incheon | South Korea |
|
| Dong-A Medical Center | Recruiting | Pusan | South Korea |
|
| Seoul university Bundang hospital | Recruiting | Seongnam-si | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| Hanyang University Seoul Hospital | Not yet recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| SNU Boramae Medical Center | Not yet recruiting | Seoul | South Korea |
|
| The Catholic Univ. of Korea Seoul St. Mary's hospital | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea, St. Vincent's Hospital | Not yet recruiting | Suwon | South Korea |
|
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital | Recruiting | Uijeongbu-si | South Korea |
|
| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| Siriraj Hospital | Recruiting | Bangkok | Thailand |
|
| Siriraj Hospital | Recruiting | Bangkok | Thailand |
|
| Srinagarind Hospital | Recruiting | Khon Kaen | Thailand |
|
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided