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

Primary Purpose

Angina Pectoris, Chest Pain

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cardiac CT
Standard care
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angina Pectoris focused on measuring coronary artery disease, angina pectoris, Stable chest pain complaints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MC Haaglanden
  • Erasmus MC
  • Havenziekenhuis
  • Maasstadziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cardiac CT

Standard care

Arm Description

Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result

Standard diagnostic management, including stress testing and/or invasive angiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall medical expenses
Overall medical expenses
Cost-effectiveness
Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.
Radiation dose
Cumulative radiation exposure at one year
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)
Quality of life
Change of quality of life at 1 year

Full Information

First Posted
June 27, 2011
Last Updated
November 11, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01393028
Brief Title
Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
Acronym
CRESCENT
Official Title
Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funds
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Chest Pain
Keywords
coronary artery disease, angina pectoris, Stable chest pain complaints

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac CT
Arm Type
Experimental
Arm Description
Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard diagnostic management, including stress testing and/or invasive angiography
Intervention Type
Other
Intervention Name(s)
Cardiac CT
Intervention Description
Cardiac CT: calcium scan and CT coronary angiography
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care according to international guidelines
Primary Outcome Measure Information:
Title
Chest pain
Description
Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up
Time Frame
1 year
Title
Class IA Revascularizations
Description
Number of revascularizations with an ESC class 1A indication
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall medical expenses
Description
Overall medical expenses
Time Frame
1 year
Title
Cost-effectiveness
Description
Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.
Time Frame
1 year
Title
Radiation dose
Description
Cumulative radiation exposure at one year
Time Frame
1 year
Title
Major adverse cardiovascular events
Description
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)
Time Frame
1 year
Title
Quality of life
Description
Change of quality of life at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
MC Haaglanden
City
Leidschendam
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Havenziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Maasstadziekenhuis
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
28174196
Citation
Lubbers M, Coenen A, Bruning T, Galema T, Akkerhuis J, Krenning B, Musters P, Ouhlous M, Liem A, Niezen A, Dedic A, van Domburg R, Hunink M, Nieman K. Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease). Circ Cardiovasc Imaging. 2017 Feb;10(2):e005295. doi: 10.1161/CIRCIMAGING.116.005295.
Results Reference
derived

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Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

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