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
  Purpose

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 Intervention
Endothelial Dysfunction
Myocardial Perfusion Abnormalities
Cardiac MRI Perfusion With Vasomotor Stress
Diabetes
Procedure: Cardiac Perfusion MRI w Vasomotor Stress

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808535

Locations
United States, California
UCLA Radiological Sciences Not yet recruiting
Los Angeles, California, United States, 91324
Contact: Wanda C Marfori, MD    310-206-2531    wmarfori@mednet.ucla.edu   
Contact: Stefan Ruehm, MD    3108250958    sruehm@mednet.ucla.edu   
Principal Investigator: Stefan Ruehm, MD         
Sub-Investigator: Jonathan Goldin, MD, PhD         
Sub-Investigator: Mayil Krishnam, MD         
Sub-Investigator: Christine Darwin, MD         
Sponsors and Collaborators
University of California, Los Angeles
Bracco Diagnostics, Inc
Investigators
Principal Investigator: Stefan Ruehm, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Stefan Ruehm, MD, UCLA
ClinicalTrials.gov Identifier: NCT00808535     History of Changes
Other Study ID Numbers: CMRI_Perfusion Study
Study First Received: December 15, 2008
Last Updated: February 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Endothelial dysfunction
Cardiac Perfusion MRI
Vasomotor Stress
Cold Pressor Test
Adenosine Stress

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 31, 2014