Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

February 6, 2009 updated by: University of California, Los Angeles

A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction

The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction.

This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30 non-diabetics to serve as healthy controls), and will include male and non-pregnant females, between the ages 18-50 years.

All eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:

  • 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.
  • Urine Albumin to Creatinine ratio for microalbuminuria.
  • Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.

After blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 91324
        • UCLA Radiological Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics.

Healthy controls from general population.

Description

Inclusion Criteria:

  • Age 18 to 50 years
  • Should be able to sign an informed consent and HIPAA Agreement
  • 30 healthy, non-diabetic individuals
  • 30 diabetic individuals without documented coronary artery disease
  • Diagnosed diabetics less than 5 years
  • HbA1c less than 8.0

Exclusion Criteria:

  • Children under 18 years and adults above 50 years
  • Type 1 DM
  • Lactating and Pregnant females
  • BMI less than 35
  • Contraindication to MRI such as pacemaker, defibrillator implants, etc.
  • Allergy to MR (paramagnetic) contrast
  • History of Angina, MI, or documented Coronary Artery Disease
  • Previous history of CHF, CABG, Angioplasty and Stenting
  • History of Valvular Heart Disease and Congenital Heart Disease
  • History of Peripheral Vascular Disease
  • History of Cardiac Arrythmias and anti-coagulation therapy
  • History of Cerebro-vascular accidents or TIA
  • History of active diabetic retinopathy and nephropathy
  • Uncontrolled hypertension (systolic > 170 and diastolic >100 mm Hg
  • End Stage Renal Disease and patients on dialysis
  • HbA1c of 8.0
  • Creatinine greater than 1.7 mg/dl
  • History of active gastrointestinal bleeding
  • History of IV drug use
  • Chronic or current steroid treatment
  • Growth hormone treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy controls
Procedure: Cardiac Perfusion MRI w Vasomotor Stress
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
diabetics
Procedure: Cardiac Perfusion MRI w Vasomotor Stress
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Bracco Diagnostics, Inc

Investigators

  • Principal Investigator: Stefan Ruehm, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRI_Perfusion Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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