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: June 12, 2014
Last verified: June 2014
  Purpose

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
Arteriosclerosis of Coronary Artery Bypass Graft
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation Using CTA to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Serum banking


Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580008

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

No publications provided

Responsible Party: Kavitha Chinnaiyan, Director, Cardiovascular Imaging Education, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00580008     History of Changes
Other Study ID Numbers: 2007-144
Study First Received: December 17, 2007
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
tomography
coronary artery disease
coronary artery bypass grafting
vein graft

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

ClinicalTrials.gov processed this record on August 27, 2014