Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01810198
• Lead Sponsor: MDDX LLC

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1631

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (13)

Walter Reed Medical Center; 🇺🇸 Bethesda, Maryland, United States

Quanta Diagnostico Nuclear, Curitiba-PR; 🇧🇷 Curitiba, Brazil

FACTS; 🇮🇳 Hyderabad, India

Centro Cardiologico Monzino; 🇮🇹 Monzino, Italy

Kangwon National University Hospital; 🇰🇷 Seoul, South Korea, Korea, Republic of

Ajou University Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea university, Guro hospital; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Seoul, Korea, Republic of

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