Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

• Conditions: Endothelial Dysfunction; Myocardial Perfusion Abnormalities; Cardiac MRI Perfusion With Vasomotor Stress; Diabetes
• Interventions: Procedure: Cardiac Perfusion MRI w Vasomotor Stress

• Registration Number: NCT00808535
• Lead Sponsor: University of California, Los Angeles

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 available

Study Timeline

• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Status Verified: 2009-02
• Study Start: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09
• Primary Completion: 2010-02
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetics	Cardiac Perfusion MRI w Vasomotor Stress	-
healthy controls	Cardiac Perfusion MRI w Vasomotor Stress	-

Trial Locations

Locations (1)

UCLA Radiological Sciences; 🇺🇸 Los Angeles, California, United States