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

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352937
• Other study ID #: 1124528
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2006
• Last updated: May 14, 2014
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2014
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Providence Veterans Affairs Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Providence VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium score		1 year	No