Study of Coronary Artery Disease by Two Types of Angiography

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. Identifier: NCT00273819
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : January 27, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Procedure: CT angiography Not Applicable

Detailed Description:


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.


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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Non-Invasive Detection of Revascularizable Cardiomyopathy
Study Start Date : October 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Detection of coronary disease by CT angiography

Secondary Outcome Measures :
  1. Disease meets latest ACC/AHA guidelines for CABG

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00273819

United States, Connecticut
VACT Healthcare System-Yale School of Medicine
West HAven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Principal Investigator: Aseem Vashist, M.D. VACHS and Yale University School of Medicine
Principal Investigator: Mehran Sadeghi, M.D. VACHS and Yale University School of Medicine Identifier: NCT00273819     History of Changes
Other Study ID Numbers: AS0006
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by VA Connecticut Healthcare System:
Congestive heart failure, LV dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases