NCT01810198

Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,631 (actual)
• Sponsor: MDDX LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Cardiac CT	Perform a non-invasive Cardiac CT Angiogram
PROCEDURE	Invasive Coronary Angiography	Patient undergoes Invasive Coronary Angiography

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2013-03-13
• Last updated: 2017-03-22

Locations

13 sites across 6 countries: United States, Brazil, India, Italy, Poland, South Korea