Status:
UNKNOWN
Less Invasive Detection and Treatment of Very Early Coronary Artery Disease in Patients With Diabetes Mellitus
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institutes of Health (NIH)
Pfizer
Conditions:
Type 2 Diabetes
Microvascular Dysfunction
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
This protocol focuses on the development of a noninvasive method of early coronary artery disease detection in diabetes. The overall hypothesis is that risk factors for the metabolic syndrome will pre...
Detailed Description
Type II Diabetes has become an epidemic in the United States. Cardiovascular disease is the most common cause of death in this population and is two to four fold higher than the general population. Th...
Eligibility Criteria
Inclusion
- Type 2 Diabetes
- Metabolic Syndrome
- Not all risk factors at goal
- Willingness to attend frequent clinic visits
- No coronary stenosis greater than 50% found on catheterization
Exclusion
- Type 1 diabetes
- GFR less than 60ml/min/1.73m2
- Females who are pregnant, lactating, not using reliable contraceptive method
- Known coronary stenosis greater than 50%
- Subjects in which stress testing would be contraindicated
- Prior heart transplantation
- Expected survival less than one year
- HIV infection
- Hepatorenal syndrome or history of liver transplant
- Contraindication to MRI
- Significant pulmonary hypertension
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00797186
Start Date
November 1 2008
End Date
December 1 2011
Last Update
May 30 2011
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22902