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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier:
NCT00352937
First received: July 14, 2006
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Phase
Coronary Arteriosclerosis
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test

Resource links provided by NLM:


Further study details as provided by Providence VA Medical Center:

Primary Outcome Measures:
  • Calcium score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00352937     History of Changes
Other Study ID Numbers: 1124528
Study First Received: July 14, 2006
Last Updated: May 14, 2014
Health Authority: United States: Federal Government

Keywords provided by 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
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014