Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease (CRESCENT)

November 11, 2014 updated by: Koen Nieman, Erasmus Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leidschendam, Netherlands
        • MC Haaglanden
      • Rotterdam, Netherlands
        • Erasmus MC
      • Rotterdam, Netherlands
        • Havenziekenhuis
      • Rotterdam, Netherlands
        • Maasstadziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac CT
Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result
Other: Cardiac CT
Cardiac CT: calcium scan and CT coronary angiography
Other: Standard care
Standard diagnostic management, including stress testing and/or invasive angiography
Other: Standard care
Standard care according to international guidelines

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall medical expenses
Time Frame: 1 year
Overall medical expenses
1 year
Cost-effectiveness
Time Frame: 1 year
Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.
1 year
Radiation dose
Time Frame: 1 year
Cumulative radiation exposure at one year
1 year
Major adverse cardiovascular events
Time Frame: 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)
1 year
Quality of life
Time Frame: 1 year
Change of quality of life at 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRESCENT-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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