Less Invasive Detection and Treatment of Very Early Coronary Artery Disease in Patients With Diabetes Mellitus
Recruitment status was: Recruiting
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:
- 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.
- 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.
- To assess which risk factors are most predictive early in disease and to demonstrate which risk factors, when treated, provide the most benefit.
- To assess whether findings on CMR predict findings on IVUS, thus, providing a noninvasive method of early disease detection.
|Type 2 Diabetes Microvascular Dysfunction||Other: Intensive risk factor management|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Less Invasive Detection and Treatment of Very Early Coronary Artery Disease in Patients With Diabetes Mellitus Using Regadenoson Stress Cardiac Magnetic Resonance Imaging|
- LDL density [ Time Frame: 1 year ]
- HDL [ Time Frame: 1 year ]
- change in microvascular perfusion [ Time Frame: 1 year ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
There is one arm in this trial. All patients receive the same therapy. The goal is to compare a noninvasive and invasive imaging technique in the same population.
Other: Intensive risk factor management
Aggressive medical and lifestyle therapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00797186
|Contact: Angela M Tayloremail@example.com|
|Contact: Anne Hedeltfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22902|
|Principal Investigator: Angela M Taylor, MD, MS|
|Sub-Investigator: Christopher Kramer, MD|
|Sub-Investigator: Amy West, MD|
|Sub-Investigator: Michael Ragosta, MD|
|Sub-Investigator: Anne Hedelt, MD|
|Sub-Investigator: Cherie Chaney, RN|
|Sub-Investigator: Joseph Aloi, MD|
|Sub-Investigator: Anthony McCall, MD|
|Sub-Investigator: Ellen Keeley, MD, MS|
|Sub-Investigator: Coleen McNamara, MD|
|Sub-Investigator: Amy Tucker, MD|
|Sub-Investigator: Lewis Lipson, MD|
|Sub-Investigator: Lawrence Gimple, MD|