Clincosm LogoSign in Get a demo

Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

Sponsor
University of California, Los Angeles (Other)
Overall Status
Unknown status
CT.gov ID
NCT00808535
Collaborator
Bracco Diagnostics, Inc (Industry)
60
Enrollment
1
Location
12.9
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiac Perfusion MRI w Vasomotor Stress

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
Study Start Date :
Feb 1, 2009
Anticipated Primary Completion Date :
Feb 1, 2010
Anticipated Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Radiological Sciences Los Angeles California United States 91324

    Sponsors and Collaborators

    • University of California, Los Angeles
    • Bracco Diagnostics, Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00808535
    Other Study ID Numbers:
    • CMRI_Perfusion Study
    First Posted:
    Dec 16, 2008
    Last Update Posted:
    Feb 9, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Endothelial dysfunction
    Cardiac Perfusion MRI
    Vasomotor Stress
    Cold Pressor Test
    Adenosine Stress
    Additional relevant MeSH terms:
    Congenital Abnormalities

    Study Results

    No Results Posted as of Feb 9, 2009