Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE)

MDDX

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Invasive Coronary Angiography; Procedure: Cardiac CT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810198

CONSERVE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,631 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,631 participants in 2 patient groups

Cardiac CT

Active Comparator group

Description:

Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)

Treatment:

Procedure: Cardiac CT

Invasive Coronary Angiography

Active Comparator group

Description:

Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography

Treatment:

Procedure: Invasive Coronary Angiography