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

NCT00580008 | Completed DMC

• 1 other identifier: 2007-144
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriosclerosis of Coronary Artery Bypass Graft; Coronary Artery Disease

Keywords

tomography; coronary artery disease; coronary artery bypass grafting; vein graft

Outcome Measures

Primary Outcomes (1)

• Morphological characteristics of vein grafts

  To identify the presence of and morphological characteristics of vein graft disease in patients at 1 and 2 years post bypass surgery.

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum banking

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Safian, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Kavitha Chinnaiyan, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Gil Raff, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Imaging Education

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)