Arteriosclerosis of Coronary Artery Bypass GraftELUCIDATE)NCT00580008
Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
An observational study of Arteriosclerosis of Coronary Artery Bypass Graft and Coronary Artery Disease, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis of Coronary Artery Bypass Graft, Coronary Artery Disease
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Evaluation Using 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.
Read the 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.
- Keywords
- tomography, coronary artery disease, coronary artery bypass grafting, vein graft
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriosclerosis of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kavitha Chinnaiyan, Corewell Health East
- Investigators
- Robert Safian, MD, Principal investigator, Corewell Health EastKavitha Chinnaiyan, MD, Principal investigator, Corewell Health EastGil Raff, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580008
- Sponsor's protocol ID
- 2007-144
- Acronym
- ELUCIDATE)
- Status last verified
- Apr 2016
- First submitted
- 17 Dec 2007
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Using CTA to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
- ClinicalTrials.gov ID
- NCT00580008
- Acronym / sponsor ID
- ELUCIDATE) / 2007-144
- Keywords
- tomography, coronary artery disease, coronary artery bypass grafting, vein graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Safian, MD principal investigator
Corewell Health East
Kavitha Chinnaiyan, MD principal investigator
Corewell Health East
Gil Raff, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriosclerosis of Coronary Artery Bypass Graft and Coronary Artery Disease, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological characteristics of vein grafts (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.