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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Pfizer
Astellas Pharma Inc
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00797186
First received: November 24, 2008
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

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 Intervention
Type 2 Diabetes
Microvascular Dysfunction
Other: Intensive risk factor management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • LDL density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HDL [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • change in microvascular perfusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
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)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797186

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

Locations
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
Pfizer
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Angela M. Taylor, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00797186     History of Changes
Other Study ID Numbers: 13761, 1 K23 HL093118-01
Study First Received: November 24, 2008
Last Updated: May 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
diabetes
dyslipidemia
microvascular dysfunction
imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014