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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac CT | Active Comparator | Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography) |
|
| Invasive Coronary Angiography | Active Comparator | Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT | Procedure | Perform a non-invasive Cardiac CT Angiogram |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MACE Endpoints |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Additional MACE Endpoints |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Economic | The secondary economic endpoint is within-trial cardiovascular costs*. *Costs will include index- and downstream CAD-related costs related to diagnostic testing, medications, hospitalizations, emergency department visits, outpatient visits, and coronary revascularizations. (Costs will also include non-CAD-related but test related costs.) | 1 year |
INCLUSION CRITERIA
EXCLUSION CRITERIA
12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35
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| Name | Affiliation | Role |
|---|---|---|
| James Min, MD | Cornell Weill Medical College | Principal Investigator |
| Dan Gebow, PhD | MDDX LLC | Study Director |
| Hyuk-Jae Chang, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Medical Center | Bethesda | Maryland | United States | |||
| Quanta Diagnostico Nuclear, Curitiba-PR |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30553687 | Derived | Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12. |
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| Invasive Coronary Angiography |
| Procedure |
Patient undergoes Invasive Coronary Angiography |
|
| Secondary Safety Endpoint | The secondary safety endpoint will be rates of serious test-related complications*. *Serious test-related complications will include contrast-induced nephropathy, hematoma requiring transfusion, arteriovenous fistula, aneurysm formation, retroperitoneal bleed, arterial dissection and any surgery for test-related complications and cumulative CAD test-related effective biological radiation dose. | 1 year |
| Quality of Life | The tertiary endpoint will be general and angina-specific quality of life, as measured by the EQ-5D Health Survey and Seattle Angina Questionnaire, respectively. | 1 year |
| Curitiba |
| Brazil |
| FACTS | Hyderabad | India |
| Centro Cardiologico Monzino | Monzino | Italy |
| Institute of Cardiology Warsaw | Warsaw | Poland |
| Kangwon National University Hospital | Seoul | South Korea | South Korea |
| Ajou University Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Gangneung Asan Hospital | Seoul | South Korea |
| Korea university, Guro hospital | Seoul | South Korea |
| Pusan National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Yeongnam University Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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