Clinical trial NCT00273819: Study of Coronary Artery Disease by Two Types of Angiography
Official title: Non-Invasive Detection of Revascularizable Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive heart failure, LV dysfunction
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2006-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection of coronary disease by CT angiography
Secondary outcomes:
measure: Disease meets latest ACC/AHA guidelines for CABG
Other outcomes:
Locations:
city: West HAven
country: United States
facility: VACT Healthcare System-Yale School of Medicine
state: Connecticut
Study officials:
affiliation: VACHS and Yale University School of Medicine
name: Aseem Vashist, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: VACHS and Yale University School of Medicine
name: Mehran Sadeghi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: