The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post-treatment improvement of peripheral artery disease
研究概览
简要总结
The aim of this study is to establish a clinically feasible simultaneous evaluation of heart and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI imaging markers in the evaluation of PAD and prediction of treatment outcome.
详细描述
We expect to enroll about 60 long-term DM patients (>10 years) from main study. Patient will receive evaluation of the perfusion in the lower limb by using blood oxygenation-level dependent (BOLD) sequence with measurement of the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles. All patients will receive cardiac MRI (cardiac function, ischemia and fibrosis) and MR angiography (severity of PAD). The baseline studies will be completed within 2 years and 3 additional follow-up studies will be performed by the end of 4th year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria include:
- •Able to understand and provide signed informed consent
- •DM history of 10 years and above
- •Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable
- •Willing to receive standard therapy such as surgery or medication
- •Age between 18-80 years old
排除标准
- •Pregnant or breast-feeding women
- •Allergic MRI contrast medium
- •Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium).
- •Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball
- •Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility
- •Patients having dialysis
结局指标
主要结局
Post-treatment improvement of peripheral artery disease
时间窗: 2 years
To determine the combined benefit of clinical and MRI imaging parameters (cardiac and lower extremities) in treatment response monitoring and treatment outcome prediction.
次要结局
未报告次要终点
研究者
Yu-Hsiang Juan
Primary investigator
Chang Gung Memorial Hospital