Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Invasive treatment
* Other: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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 The exclusion criteria include: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Invasive treatment<br>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 | Procedure: Invasive treatment<br>* 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<br>* Other names: Surgery or endovascular treatment;|
| Active Comparator: Conservative treatment<br>rehabilitation with medical therapy | Other: Conservative treatment<br>* rehabilitation with medical therapy<br>* Other names: rehabilitation with medical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment improvement of peripheral artery disease | To determine the combined benefit of clinical and MRI imaging parameters (cardiac and lower extremities) in treatment response monitoring and treatment outcome prediction. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function