Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

NCT00808535 | Unknown

• 1 other identifier: CMRI_Perfusion Study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Myocardial Perfusion Abnormalities; Cardiac MRI Perfusion With Vasomotor Stress; Diabetes

Keywords

Endothelial dysfunction; Cardiac Perfusion MRI; Vasomotor Stress; Cold Pressor Test; Adenosine Stress

Study Arms (2)

diabetics

Procedure: Cardiac Perfusion MRI w Vasomotor Stress

healthy controls

Procedure: Cardiac Perfusion MRI w Vasomotor Stress

Interventions

Cardiac Perfusion MRI w Vasomotor Stress PROCEDURE

All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.

diabetics; healthy controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age 18 to 50 years
• Should be able to sign an informed consent and HIPAA Agreement
• healthy, non-diabetic individuals
• diabetic individuals without documented coronary artery disease
• Diagnosed diabetics less than 5 years
• HbA1c less than 8.0

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Bracco Diagnostics, Inc: collaborator

Study Sites (1)

UCLA Radiological Sciences

Los Angeles, California, 91324, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stefan Ruehm, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 9, 2009

Record last verified: 2009-02

Locations

US (1)