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Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

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ClinicalTrials.gov Identifier: NCT00808535
Recruitment Status : Unknown
Verified February 2009 by University of California, Los Angeles.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2008
Last Update Posted : February 9, 2009
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date December 15, 2008
First Posted Date December 16, 2008
Last Update Posted Date February 9, 2009
Study Start Date February 2009
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
Official Title A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Endothelial Dysfunction
  • Myocardial Perfusion Abnormalities
  • Cardiac MRI Perfusion With Vasomotor Stress
  • Diabetes
Intervention 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.
Study Groups/Cohorts
  • diabetics
    Intervention: Procedure: Cardiac Perfusion MRI w Vasomotor Stress
  • healthy controls
    Intervention: Procedure: Cardiac Perfusion MRI w Vasomotor Stress
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December¬†15,¬†2008)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2010
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00808535
Other Study ID Numbers CMRI_Perfusion Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stefan Ruehm, MD, UCLA
Study Sponsor University of California, Los Angeles
Collaborators Bracco Diagnostics, Inc
Investigators
Principal Investigator: Stefan Ruehm, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date February 2009