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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Endothelial Dysfunction; Myocardial Perfusion Abnormalities; Cardiac MRI Perfusion With Vasomotor Stress
• Intervention / Treatment: Procedure: Cardiac Perfusion MRI w Vasomotor Stress

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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

• Sponsor: University of California, Los Angeles
• Collaborators: Bracco Diagnostics, Inc
• Investigators: Principal Investigator: Stefan Ruehm, MD, University of California, Los Angeles

Study record dates

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: Endothelial dysfunction; Cold Pressor Test; Cardiac Perfusion MRI; Vasomotor Stress; Adenosine Stress
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CMRI_Perfusion Study