NCT01068535Unknown不适用
Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- ktrans of the carotid artery wall
研究概览
简要总结
The purpose of this study is to compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting glucose) versus those women who are normal weight and with normal cholesterol, blood fats, blood pressure, and blood sugar. We are using a novel technology to measure vascular permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The primary variable is ktrans ratio which is a mathematically derived quantity obtained from DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.
详细描述
This study involves a phone screen & 2 study visits:
- Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height & weight measurement, vital signs, and waist & hip measurements. This study lasts up to 90 minutes.
- MRI visit (to occur within a week of screening visit) occurs once serum pregnancy & creatinine results are received & only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
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
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal women (age 35-50)
- •still having menstrual periods
排除标准
- •History of diabetes mellitus
- •History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- •Serum creatinine >1.2 mg/dL (eGFR <60 ml/min.)
- •Active rheumatologic disease
- •Use of hormonal contraception*
- •Pregnant or planning a pregnancy within the next 3 months
- •Fasting triglycerides ≥ 500 mg/dL
- •Fasting LDL-C ≥ 190 mg/dL
- •Currently taking lipid lowering medications*
- •Currently taking vaso-active (blood pressure) medications*
- •Hypertension: SBP ≥ 140 and or DBP ≥90 mm Hg
- •Chronic use of aspirin (prn use is allowed)
- •Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
- •Tobacco use within 3 months of starting study
- •Participation in another clinical trial within the last 30 days
- •MRI specific exclusion criteria:
- •History of claustrophobia
- •History of decrease in kidney function (eGFR <60 ml/min.)
- •History of reaction to a contrast medium or dye used for an MRI, CT Scan, or X-ray
- •History of significant anemia or other blood disease
- •History of seizures
- •MRI-incompatible metal such as internal metal hardware or devices * Drugs within the following classifications are exclusionary: Antilipemics, antilipidemics, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, and all hormonal contraceptives
结局指标
主要结局
ktrans of the carotid artery wall
时间窗: baseline
Ktrans is a transfer constant that is a measure of vascular permeability.
次要结局
- carotid artery intima-media thickness as measured by MRI(baseline)
研究者
研究点 (1)
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