Study of Coronary Artery Disease by Two Types of Angiography

Not Applicable

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00273819
• Lead Sponsor: VA Connecticut Healthcare System

Brief Summary

The purpose of this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.

Detailed Description

Objective:

In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. With the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. The goal of this study is to compare non-invasive computed tomography (CT) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. Revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex).

Research Design:

This study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography.

Methods:

Subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. Exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). We would like to enroll 30 patients. After giving informed consent, all eligible patients will undergo CT angiography, performed using new multi-slice technology. The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Study Completion: 2007-06
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-24
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Congestive heart failure with EF<40%
• Age> 18 years

Exclusion Criteria

• Contrast allergy
• Renal insufficiency
• Inability or unwillingness to sign a consent
• Diabetes Mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection of coronary disease by CT angiography

Secondary Outcome Measures

Name	Time	Method
Disease meets latest ACC/AHA guidelines for CABG

Trial Locations

Locations (1)

VACT Healthcare System-Yale School of Medicine; 🇺🇸 West HAven, Connecticut, United States