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Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test

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ClinicalTrials.gov Identifier: NCT00352937
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.

Condition or disease Phase
Coronary Arteriosclerosis Phase 3

Detailed Description:

Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD).

Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD.

The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.


Study Design

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
Study Start Date : March 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Calcium score [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients without prior CAD referred for nuclear stress testing
Criteria

Inclusion Criteria:

  • Referred for a clinical indicated stress SPECT MPI
  • Adequate IV access in both arms

Exclusion Criteria:

  • History of coronary angioplasty or stent placement
  • History of coronary bypass surgery
  • Angiographic history of flow-limiting CAD
  • Documented history of elevated cardiac markers
  • Documented history of injury or infarct on ECG
  • Absence of sinus rhythm
  • Current history of renal insufficiency
  • Known allergy to contrast dye
  • Pregnant
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): NCT00352937


Locations
United States, Rhode Island
Providence Veterans Affairs Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Providence VA Medical Center
Investigators
Principal Investigator: Wen-Chih Wu, MD Providence VAMC
Principal Investigator: Victor H Shin, MD Providence VAMC
More Information

Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00352937     History of Changes
Other Study ID Numbers: 1124528
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014

Keywords provided by Wen-Chih Wu, Providence VA Medical Center:
Coronary Arteriosclerosis
Tomography, X-Ray Computed
Tomography, Emission-Computed, Single-Photon

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases