Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Not Applicable

Terminated

• Conditions: Angina Pectoris; Chest Pain
• Interventions: Other: Cardiac CT; Other: Standard care

• Registration Number: NCT01393028
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Men and women aged >18 years.
• Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.

Exclusion Criteria

• A history of surgical or percutaneous coronary revascularization
• Non-revascularized angiographic obstructive coronary artery disease (>50% diameter reduction).
• Normal invasive coronary angiography or stress imaging less than 1 years ago.
• Inability or unwillingness to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac CT	Cardiac CT	Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result
Standard care	Standard care	Standard diagnostic management, including stress testing and/or invasive angiography

Primary Outcome Measures

Name	Time	Method
Chest pain	1 year	Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up
Class IA Revascularizations	1 year	Number of revascularizations with an ESC class 1A indication

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	1 year	Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.
Major adverse cardiovascular events	1 year	Composite endpoint of adverse cardiovascular events, including: All-cause mortality Non-fatal myocardial infarction Unstable angina requiring hospital admission Late revascularization procedures (\>6 months after initial evaluation)
Overall medical expenses	1 year	Overall medical expenses
Radiation dose	1 year	Cumulative radiation exposure at one year
Quality of life	1 year	Change of quality of life at 1 year

Trial Locations

Locations (4)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

MC Haaglanden; 🇳🇱 Leidschendam, Netherlands

Maasstadziekenhuis; 🇳🇱 Rotterdam, Netherlands

Havenziekenhuis; 🇳🇱 Rotterdam, Netherlands