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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Type 2 Diabetes

Metabolic Syndrome

Not all risk factors at goal

See 2 more

Treatment Details

Interventions

Intensive risk factor management (Behavioural Intervention)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Intensive therapyExperimental Treatment1 Intervention

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

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