Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

Status unconfirmed

Conditions studied: Endothelial Dysfunction, Myocardial Perfusion Abnormalities, Cardiac MRI Perfusion With Vasomotor Stress, Diabetes

In brief

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.

Key facts

Study ID

NCT00808535

Run by

University of California, Los Angeles

People needed

60

Starts

2009-02-01

Expected to finish

2010-03-01

Last updated by the study team

2009-02-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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