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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
National Institutes of Health (NIH)
Astellas Pharma Inc
Information provided by:
University of Virginia

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 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.

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
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
Study Start Date : November 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Intensive therapy
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.

Primary Outcome Measures :
  1. LDL density [ Time Frame: 1 year ]
  2. HDL [ Time Frame: 1 year ]
  3. change in microvascular perfusion [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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 Taylor 434-243-9396 amt6b@virginia.edu
Contact: Anne Hedelt 434-243-4791 ach2t@virginia.edu

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         
Sponsors and Collaborators
University of Virginia
National Institutes of Health (NIH)
Astellas Pharma Inc

Responsible Party: Angela M. Taylor, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00797186     History of Changes
Other Study ID Numbers: 13761
1K23HL093118-01 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Keywords provided by University of Virginia:
microvascular dysfunction

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases