Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

University of California, Los Angeles (UCLA)

Status: Unknown

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

Treatments: Procedure: Cardiac Perfusion MRI w Vasomotor Stress

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00808535

CMRI_Perfusion Study

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

diabetics

Treatment:

Procedure: Cardiac Perfusion MRI w Vasomotor Stress

healthy controls

Treatment:

Procedure: Cardiac Perfusion MRI w Vasomotor Stress