Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments cardiac ct, invasive coronary angiography
Sponsor MDDX LLC
Collaborator GE Healthcare
Start date December 2012
End date February 2018
Trial size 1500 participants
Trial identifier NCT01810198, CONSERVE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
Arm
(Active Comparator)
Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
cardiac ct
Perform a non-invasive Cardiac CT Angiogram
(Active Comparator)
Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography
invasive coronary angiography
Patient undergoes Invasive Coronary Angiography

Primary Outcomes

Measure
MACE Endpoints
time frame: 1 year

Secondary Outcomes

Measure
Additional MACE Endpoints
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
Principal investigator James Min, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by MDDX LLC.