Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Chest Pain Clinical Trial

— CRESCENT  

Official title:

Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01393028
• Other study ID #: CRESCENT-11
• Status: Terminated
• Phase: N/A
• First received: June 27, 2011
• Last updated: November 11, 2014
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina Pectoris
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Cardiac CT
Cardiac CT: calcium scan and CT coronary angiography
• Standard care
Standard care according to international guidelines

Locations

Country	Name	City	State
Netherlands	MC Haaglanden	Leidschendam
Netherlands	Erasmus MC	Rotterdam
Netherlands	Havenziekenhuis	Rotterdam
Netherlands	Maasstadziekenhuis	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest pain	Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up	1 year	No
Primary	Class IA Revascularizations	Number of revascularizations with an ESC class 1A indication	1 year	No
Secondary	Overall medical expenses	Overall medical expenses	1 year	No
Secondary	Cost-effectiveness	Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.	1 year	No
Secondary	Radiation dose	Cumulative radiation exposure at one year	1 year	Yes
Secondary	Major adverse cardiovascular events	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)	1 year	Yes
Secondary	Quality of life	Change of quality of life at 1 year	1 year	No