Study of Coronary Artery Disease by Two Types of Angiography
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Congestive Heart Failure focused on measuring Congestive heart failure, LV dysfunction
Eligibility 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
Sites / Locations
- VACT Healthcare System-Yale School of Medicine
Outcomes
Primary Outcome Measures
Detection of coronary disease by CT angiography
Secondary Outcome Measures
Disease meets latest ACC/AHA guidelines for CABG
Full Information
NCT ID
NCT00273819
First Posted
January 5, 2006
Last Updated
January 24, 2009
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00273819
Brief Title
Study of Coronary Artery Disease by Two Types of Angiography
Official Title
Non-Invasive Detection of Revascularizable Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive heart failure, LV dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
CT angiography
Primary Outcome Measure Information:
Title
Detection of coronary disease by CT angiography
Secondary Outcome Measure Information:
Title
Disease meets latest ACC/AHA guidelines for CABG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aseem Vashist, M.D.
Organizational Affiliation
VACHS and Yale University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehran Sadeghi, M.D.
Organizational Affiliation
VACHS and Yale University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VACT Healthcare System-Yale School of Medicine
City
West HAven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
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Study of Coronary Artery Disease by Two Types of Angiography
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