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OpenTrials
Completed

NCT Number: NCT00273819

Study of Coronary Artery Disease by Two Types of Angiography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VACT Healthcare System-Yale School of Medicine

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Angiography

Procedure

Primary outcomes

  1. Detection of coronary disease by CT angiography

Secondary outcomes

  1. Disease meets latest ACC/AHA guidelines for CABG

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Official study title

Non-Invasive Detection of Revascularizable Cardiomyopathy

Important dates

Study start
2005
Study completion
2007
First posted
Jan 9, 2006
Registry last updated
Jan 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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