A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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