- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428961
Diabetes Genome Project: A Prospective Registry to Identify Genetic Variation Among Diabetic Patients (DGP)
Diabetic Genome Project: A Multi-Phase Prospective Registry to Identify Genetic Variation Among Diabetic Patients Undergoing Coronary Revascularization
Previous scientific research has found multiple genes that affect the risk for developing heart disease or complications during the treatment of heart disease. Less is currently known about how patients with heart disease may differ on the basis of other ailments they may have and how these other ailments may affect their treatment and prognosis. For this reason, researchers at the Mid America Heart Institute are conducting this research to find out how genes affect heart disease and recovery following angioplasty. The study will include patients with diabetes in order to determine if their genes are different from patients without diabetes.
A total of 1,607 patients were enrolled. There were 2 groups of patients selected for this study. The first group of patients included into the study will be those that are scheduled to have a diagnostic angiogram only. The second group of patients were those that had along with the angiogram a percutaneous transluminal coronary angioplasty, PTCA and or the use of a device called a coronary "stent", designed to help prop open the artery and to help avoid collapse. Samples for both groups will be stored for 30 years. After this time, all samples will be destroyed. Ultimately, we are hopeful that we will identify genes that will identify groups of patients at risk for heart disease.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital Mid America Heart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female gender
- Diabetes mellitus or no diabetes mellitus
- Candidate for percutaneous coronary intervention
- Informed consent
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven P Marso, MD, University of Missouri Kansas City, Saint Luke's Hospital
Publications and helpful links
General Publications
- Marso SP, Mehta SK, Frutkin A, House JA, McCrary JR, Kulkarni KR. Low adiponectin levels are associated with atherogenic dyslipidemia and lipid-rich plaque in nondiabetic coronary arteries. Diabetes Care. 2008 May;31(5):989-94. doi: 10.2337/dc07-2024. Epub 2008 Feb 5.
- Lindsey JB, House JA, Kennedy KF, Marso SP. Diabetes duration is associated with increased thin-cap fibroatheroma detected by intravascular ultrasound with virtual histology. Circ Cardiovasc Interv. 2009 Dec;2(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.109.876672. Epub 2009 Oct 13.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-102
- ADA 7-04-CR-28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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