Expired Study
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Royal Oak, Michigan 48073


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2007-144


NCT ID:

NCT00580008


Secondary ID:


Study Acronym:

ELUCIDATE)


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

William Beaumont Hospitals


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

178


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert Safian, MD
Principal Investigator
William Beaumont Hospitals

Study Dates

Start Date:December 2007
Completion Date:August 2011
Completion Type:Actual
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 19, 2016
First Received Date:December 17, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Morphological characteristics of vein grafts
Time Frame:two years
Safety Issues:False
Description:To identify the presence of and morphological characteristics of vein graft disease in patients at 1 and 2 years post bypass surgery.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:William Beaumont Hospitals

Samples and Retentions

Sample Retention:Samples With DNA
Description: Serum banking
Study Population: Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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