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
  Purpose

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 Intervention
Congestive Heart Failure
Procedure: CT angiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Non-Invasive Detection of Revascularizable Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Detection of coronary disease by CT angiography

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

Estimated Enrollment: 30
Study Start Date: October 2005
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00273819

Locations
United States, Connecticut
VACT Healthcare System-Yale School of Medicine
West HAven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273819     History of Changes
Other Study ID Numbers: AS0006, 00795
Study First Received: January 5, 2006
Last Updated: January 24, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014