Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of California, Los Angeles.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00808535
First received: December 15, 2008
Last updated: February 6, 2009
Last verified: February 2009

December 15, 2008
February 6, 2009
February 2009
February 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00808535 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Healthy controls from general population.

  • Endothelial Dysfunction
  • Myocardial Perfusion Abnormalities
  • Cardiac MRI Perfusion With Vasomotor Stress
  • Diabetes
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
    Intervention: Procedure: Cardiac Perfusion MRI w Vasomotor Stress
  • healthy controls
    Intervention: Procedure: Cardiac Perfusion MRI w Vasomotor Stress
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
United States
 
NCT00808535
CMRI_Perfusion Study
No
Stefan Ruehm, MD, UCLA
University of California, Los Angeles
Bracco Diagnostics, Inc
Principal Investigator: Stefan Ruehm, MD University of California, Los Angeles
University of California, Los Angeles
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP