Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)
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| First Received Date ICMJE | December 17, 2007 | ||||||||||||
| Last Updated Date | March 26, 2013 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Morphological characteristics of vein grafts [ Time Frame: two years ] [ Designated as safety issue: No ] To identify the presence of and morphological characteristics of vein graft disease in patients at 1 and 2 years post bypass surgery. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00580008 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE) | ||||||||||||
| Official Title ICMJE | Evaluation Using CTA to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE) | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Serum banking |
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| Sampling Method | Probability Sample | ||||||||||||
| Study Population | Referrals from physicians' office Patients' self-referral Age greater than 18 years old Both genders |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||||||
| Estimated Completion Date | June 2014 | ||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00580008 | ||||||||||||
| Other Study ID Numbers ICMJE | 2007-144 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Kavitha Chinnaiyan, William Beaumont Hospitals | ||||||||||||
| Study Sponsor ICMJE | William Beaumont Hospitals | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | William Beaumont Hospitals | ||||||||||||
| Verification Date | March 2013 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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