Study of Coronary Artery Disease by Two Types of Angiography

This study has been completed.
Sponsor:
Information provided by:
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00273819
First received: January 5, 2006
Last updated: January 24, 2009
Last verified: January 2009

January 5, 2006
January 24, 2009
October 2005
Not Provided
Detection of coronary disease by CT angiography
Same as current
Complete list of historical versions of study NCT00273819 on ClinicalTrials.gov Archive Site
Disease meets latest ACC/AHA guidelines for CABG
Same as current
Not Provided
Not Provided
 
Study of Coronary Artery Disease by Two Types of Angiography
Non-Invasive Detection of Revascularizable Cardiomyopathy

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Congestive Heart Failure
Procedure: CT angiography
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00273819
AS0006, 00795
Not Provided
Not Provided
VA Connecticut Healthcare System
Not Provided
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
VA Connecticut Healthcare System
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP