Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
This trial is active, not recruiting.
|Condition||peripheral arterial disease|
|Treatments||invasive treatment, conservative treatment|
|Sponsor||Chang Gung Memorial Hospital|
|Start date||May 2016|
|End date||April 2019|
|Trial size||130 participants|
|Trial identifier||NCT02850432, CMRPG3F1311|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Post-treatment improvement of peripheral artery disease
time frame: 2 years
Male or female participants from 18 years up to 70 years old.
- 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 18-70 years old
- 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
|Official title||The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM|
|Principal investigator||Yu-Hsiang Juan, MD|
|Description||We expect to enroll 130 long-term DM patients (>10 years) from main study. Patient will be separated into two groups with 65 patients each (13 without PAD and 52 with PAD). Group A focuses on evaluation of the perfusion in the lower limb by using blood oxygenation-level dependent (BOLD) and dynamic contrast enhancement (DCE) sequences. Group B measures the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles. All patients from both groups 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 for the patients with PAD, 3 additional follow-up studies will be performed by the end of 4th year.|
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