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

This study has been terminated.
(Insufficient funds)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393028
First Posted: July 13, 2011
Last Update Posted: November 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Koen Nieman, Erasmus Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Koen Nieman, Erasmus Medical Center:

Primary Outcome Measures:
  • Chest pain [ Time Frame: 1 year ]
    Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up

  • Class IA Revascularizations [ Time Frame: 1 year ]
    Number of revascularizations with an ESC class 1A indication


Secondary Outcome Measures:
  • Overall medical expenses [ Time Frame: 1 year ]
    Overall medical expenses

  • Cost-effectiveness [ Time Frame: 1 year ]
    Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.

  • Radiation dose [ Time Frame: 1 year ]
    Cumulative radiation exposure at one 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)


  • Quality of life [ Time Frame: 1 year ]
    Change of quality of life at 1 year


Enrollment: 350
Study Start Date: July 2011
Study Completion Date: August 2014
Primary Completion Date: August 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393028


Locations
Netherlands
MC Haaglanden
Leidschendam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Havenziekenhuis
Rotterdam, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Koen Nieman, Dr K Nieman, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01393028     History of Changes
Other Study ID Numbers: CRESCENT-11
First Submitted: June 27, 2011
First Posted: July 13, 2011
Last Update Posted: November 13, 2014
Last Verified: November 2014

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

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