Peripheral Arterial Disease
Conditions
Keywords
Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInvasive treatment
Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol
OTHERConservative treatment
rehabilitation with medical therapy
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria include: 1. Able to understand and provide signed informed consent 2. DM history of 10 years and above 3. Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable 4. Willing to receive standard therapy such as surgery or medication 5. Age between 18-80 years old The
Exclusion criteria
include: 1. Pregnant or breast-feeding women 2. Allergic MRI contrast medium 3. Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium). 4. Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball 5. Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility 6. Patients having dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment improvement of peripheral artery disease | 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. |
Countries
Taiwan
Contacts
Primary ContactYu-Hsiang Juan, MD
Outcome results
None listed