Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Cardiac CT; Procedure: Invasive Coronary Angiography

• 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

Arm && Interventions

Group	Intervention	Description
Cardiac CT	Cardiac CT	Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
Invasive Coronary Angiography	Invasive Coronary Angiography	Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography

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

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

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

Institute of Cardiology Warsaw; 🇵🇱 Warsaw, Poland

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