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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kavitha Chinnaiyan, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00580008
First received: December 17, 2007
Last updated: March 26, 2013
Last verified: March 2013

December 17, 2007
March 26, 2013
December 2007
September 2013   (final data collection date for primary outcome measure)
Morphological characteristics of vein grafts [ Time Frame: two years ] [ Designated as safety issue: No ]
To identify the presence of and morphological characteristics of vein graft disease in patients at 1 and 2 years post bypass surgery.
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Complete list of historical versions of study NCT00580008 on ClinicalTrials.gov Archive Site
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Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
Evaluation Using CTA to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Serum banking

Probability Sample

Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders

  • Arteriosclerosis of Coronary Artery Bypass Graft
  • Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580008
2007-144
Yes
Kavitha Chinnaiyan, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: Robert Safian, MD William Beaumont Hospitals
Principal Investigator: Kavitha Chinnaiyan, MD William Beaumont Hospitals
Principal Investigator: Gil Raff, MD William Beaumont Hospitals
William Beaumont Hospitals
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP