NCT00797186

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. 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. 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. 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. 4.To assess whether findings on CMR predict findings on IVUS, thus, providing a noninvasive method of early disease detection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

3.1 years

First QC Date

November 24, 2008

Last Update Submit

May 26, 2011

Conditions

Type 2 DiabetesMicrovascular Dysfunction

Keywords

diabetesdyslipidemiamicrovascular dysfunctionimaging

Outcome Measures

Primary Outcomes (3)

  • LDL density

    1 year

  • HDL

    1 year

  • change in microvascular perfusion

    1 year

Study Arms (1)

Intensive therapy

OTHER

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

Interventions

Intensive risk factor managementOTHER

Aggressive medical and lifestyle therapy.

Intensive therapy

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Central Study Contacts

Angela M Taylor

CONTACT

434-243-9396amt6b@virginia.edu

Anne Hedelt

CONTACT

434-243-4791ach2t@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(1)