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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-04-30

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.

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Invasive 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

Group Type ACTIVE_COMPARATOR

Invasive treatment

Intervention Type PROCEDURE

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

Conservative treatment

rehabilitation with medical therapy

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type OTHER

rehabilitation with medical therapy

Interventions

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Invasive 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

Intervention Type PROCEDURE

Conservative treatment

rehabilitation with medical therapy

Intervention Type OTHER

Other Intervention Names

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Surgery or endovascular treatment rehabilitation with medical therapy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No