Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
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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) |
Serum banking
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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 |
Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders
Inclusion Criteria:
- Ability to provide informed consent.
- Age equal to or greater than 18 years.
- One(-/+60days), 3 (-/+60days), 5 (-/+60days), or 7 (-/+60days) years after coronary artery bypass graft surgery.
Exclusion Criteria:
- Renal (kidney) insufficiency (creatinine greater than or equal to 1.6) or renal (kidney) failure requiring dialysis.
- Atrial fibrillation (type of heart rhythm) or other markedly irregular rhythm.
- Inability or refusal to provide informed consent.
- Pregnancy or unknown pregnancy status.
- Age less than 18 years.
- 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.
- 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).
- Known contrast dye allergy.
Contacts and Locations| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| 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: | March 20, 2012 |
| 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 Coronary Artery Disease Myocardial Ischemia Coronary Disease |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
