Less Invasive Detection and Treatment of Very Early Coronary Artery Disease in Patients With Diabetes Mellitus

Status unconfirmed · Not applicable

Conditions studied: Type 2 Diabetes, Microvascular Dysfunction

In brief

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 predict invasive findings on intravascular ultrasound (IVUS) and noninvasive findings on cardiac magnetic resonance (CMR) perfusion imaging. Secondary objectives will include demonstrating the relative importance of individual risk factors early in disease, demonstrating the positive effects of aggressive risk factor modification on disease, demonstrating the relative importance of treatment of individual risk factors on disease progression or stabilization, and that invasive findings on IVUS will predict noninvasive findings with CMR. Such techniques may allow earlier noninvasive detection of disease as well as tailor treatment early in the disease process making prevention more cost effective. The specific aims of this proposal are as follows: 1. To assess whether risk factors for coronary artery disease, both known and novel, predict quantitative and qualitative plaque characteristics on IVUS and alterations in myocardial blood flow on CMR. 2. To assess whether improvements in risk factors through aggressive treatment improve microvascular function as measured by CMR and plaque stabilization and/or regression as measured by IVUS. 3. To assess which risk factors are most predictive early in disease and to demonstrate which risk factors, when treated, provide the most benefit. 4. To assess whether findings on CMR predict findings on IVUS, thus, providing a noninvasive method of early disease detection.

Key facts

Study ID

NCT00797186

Run by

University of Virginia

People needed

150

Starts

2008-11-01

Expected to finish

2011-12-01

Last updated by the study team

2011-05-30

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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