Less Invasive Detection and Treatment of Very Early Coronary Artery Disease in Patients With Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00797186|
Recruitment Status : Unknown
Verified May 2011 by University of Virginia.
Recruitment status was: Recruiting
First Posted : November 25, 2008
Last Update Posted : May 30, 2011
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.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Microvascular Dysfunction||Other: Intensive risk factor management|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
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.
- LDL density [ Time Frame: 1 year ]
- HDL [ Time Frame: 1 year ]
- change in microvascular perfusion [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797186
|Contact: Angela M Taylorfirstname.lastname@example.org|
|Contact: Anne Hedeltemail@example.com|
|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|