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

This study is currently recruiting participants.
Verified July 2011 by Erasmus Medical Center
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01393028
First received: June 27, 2011
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Angina Pectoris
Chest Pain
 Other: Cardiac CT
Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Chest pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up

  • Class IA Revascularizations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of revascularizations with an ESC class 1A indication


Secondary Outcome Measures:
  • Overall medical expenses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Overall medical expenses

  • Cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.

  • Radiation dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Cumulative radiation exposure at one year

  • Major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change of quality of life at 1 year


Estimated Enrollment: 1350
Study Start Date: July 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Standard care
Standard diagnostic management, including stress testing and/or invasive angiography
 Other: Standard care
Standard care according to international guidelines

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393028

Contacts
Contact: Koen Nieman, MD, PhD +31 10 6 3333 4340 k.nieman@erasmusmc.nl
Contact: Tjebbe W Galema, MD, PhD +31 10 6 8126 8378 t.w.galema@erasmusmc.nl

Locations
Netherlands
MC Haaglanden Not yet recruiting
Leidschendam, Netherlands
Contact: Joop Schreur, MD         jhmschreur@gmail.com    
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: Koen Nieman, MD, PhD     +31 6 3333 4340     k.nieman@erasmusmc.nl    
Contact: Tjebbe Galema, MD, PhD     +31 6 8126 8378     t.w.galema@erasmusmc.nl    
Havenziekenhuis Not yet recruiting
Rotterdam, Netherlands
Contact: Boudewijn J Krenning, MD, PhD         b.krenning@havenziekenhuis.nl    
Maasstadziekenhuis Not yet recruiting
Rotterdam, Netherlands
Contact: Tobias Bruning, MD, PhD         bruningt@maasstadziekenhuis.nl    
Sponsors and Collaborators
Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Koen Nieman, Erasmus MC
ClinicalTrials.gov Identifier: NCT01393028     History of Changes
Other Study ID Numbers: CRESCENT-11
Study First Received: June 27, 2011
Last Updated: July 12, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
coronary artery disease
angina pectoris
Stable chest pain complaints

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 23, 2013