Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE) (ELUCIDATE))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580008
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Kavitha Chinnaiyan, William Beaumont Hospitals

Brief Summary:
The purpose of clinical research is to look at the nature of disease and try to develop improved methods to diagnose and treat disease.The goal of this study is to evaluate the use of computed tomography (CT) scan of the heart in the diagnosis of disease in vein grafts after bypass surgery.

Condition or disease
Arteriosclerosis of Coronary Artery Bypass Graft Coronary Artery Disease

Detailed Description:

Patients who have bypass surgery with using vein grafts from their legs (saphenous veins) have a very high risk of developing blockages in the grafts. It has been shown in previous studies that the progression of disease in vein grafts is very quick and can result in chest pain, heart attacks or death. In the past, evaluation of the grafts was possible with heart catheterization only. The technique of CT scan is currently considered an effective way to look at vein grafts as well as the arteries around the heart to identify blockages.

Certain blood proteins have been associated with rapid progression of vein graft blockages. Our purpose is to not only to identify blockages at different stages after bypass surgery, but to investigate the causes of the rapid progression of the disease, including clinical history, risk factors and the blood proteins.

Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation Using CTA to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
Study Start Date : December 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Primary Outcome Measures :
  1. Morphological characteristics of vein grafts [ Time Frame: two years ]
    To identify the presence of and morphological characteristics of vein graft disease in patients at 1 and 2 years post bypass surgery.

Biospecimen Retention:   Samples With DNA
Serum banking

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders

Inclusion Criteria:

  1. Ability to provide informed consent.
  2. Age equal to or greater than 18 years.
  3. One(-/+60days), 3 (-/+60days), 5 (-/+60days), or 7 (-/+60days) years after coronary artery bypass graft surgery.

Exclusion Criteria:

  1. Renal (kidney) insufficiency (creatinine greater than or equal to 1.6) or renal (kidney) failure requiring dialysis.
  2. Atrial fibrillation (type of heart rhythm) or other markedly irregular rhythm.
  3. Inability or refusal to provide informed consent.
  4. Pregnancy or unknown pregnancy status.
  5. Age less than 18 years.
  6. Clinical instability as deemed by the attending physician, including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), refractory hypertension (high blood pressure) (systolic blood pressure greater than 180 mmHg), sustained ventricular or atrial arrhythmia (types of heart rhythm) requiring intravenous medications.
  7. Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease (temporary narrowing of the tubes in the lungs) (or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block (chambers in the heart not beating in sync), second-degree atrioventricular block (chambers in the heart not beating in sync).
  8. Known contrast dye allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00580008

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Robert Safian, MD William Beaumont Hospitals
Principal Investigator: Kavitha Chinnaiyan, MD William Beaumont Hospitals
Principal Investigator: Gil Raff, MD William Beaumont Hospitals

Responsible Party: Kavitha Chinnaiyan, Director, Cardiovascular Imaging Education, William Beaumont Hospitals Identifier: NCT00580008     History of Changes
Other Study ID Numbers: 2007-144
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Kavitha Chinnaiyan, William Beaumont Hospitals:
coronary artery disease
coronary artery bypass grafting
vein graft

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