Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Cardiac CT, Catheterization
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECardiac CT
Perform a non-invasive Cardiac CT Angiogram
PROCEDUREInvasive Coronary Angiography
Patient undergoes Invasive Coronary Angiography
Sponsors
GE Healthcare
MDDX LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years 2. Patients providing written informed consent 3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication
Exclusion criteria
1. Known CAD (myocardial infarction, PCI, CABG) 2. ACC/AHA Class I or III indication for ICA 3. Non-cardiac illness with life expectancy \<2 years 4. Inability to provide written informed consent 5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device 6. Pregnant women 7. Allergy to iodinated contrast agent 8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate \<30 ml/min 9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.) 10. Heart rate ≥100 beats per minute 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE Endpoints | 1 year | * Death * Non-fatal myocardial infarction * Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) * Stroke * Urgent or emergent coronary revascularization * Cardiovascular hospitalization (including for angina, heart failure or other) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional MACE Endpoints | 1 year | * The primary composite MACE endpoint plus major bleeding. * The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage. * The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic | 1 year | 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.) |
| Secondary Safety Endpoint | 1 year | 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. |
| Quality of Life | 1 year | 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. |
Countries
Brazil, India, Italy, Poland, South Korea, United States
Outcome results
None listed