Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction

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

Intervention / Treatment
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* Procedure: Cardiac Perfusion MRI w Vasomotor Stress


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetics<br> | Procedure: Cardiac Perfusion MRI w Vasomotor Stress<br>* All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.<br>|
| healthy controls<br> | Procedure: Cardiac Perfusion MRI w Vasomotor Stress<br>* All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial dysfunction, Cardiac Perfusion MRI, Vasomotor Stress, Cold Pressor Test, Adenosine Stress