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Completed

NCT Number: NCT00580008

Evaluation Using Computed Tomography Angiography (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Morphological characteristics of vein grafts

    Time frame: two years

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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

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

Acronym: ELUCIDATE)

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2007
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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