Recruiting

Coronary Artery Disease

Sponsor:

University of Virginia

Code:

NCT00797186

Conditions

Type 2 Diabetes

Microvascular Dysfunction

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Intensive risk factor management

Study Details

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.

Conditions

Type 2 Diabetes

Microvascular Dysfunction

Study ID

NCT00797186

Start date

Nov, 2008

Status verified date

May, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Intensive risk factor management

Aggressive medical and lifestyle therapy.

Primary outcome measure

  • LDL density [ Time Frame: 1 year ]
  • HDL [ Time Frame: 1 year ]
  • change in microvascular perfusion [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22902

Principal Investigator:

Angela M Taylor, MD, MS

More Information

Sponsor

University of Virginia

Last update posted

May 30, 2011

Last verified

May, 2011

Keywords

  • diabetes
  • dyslipidemia
  • microvascular dysfunction
  • imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2011-05-30.