Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
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
invasive treatment Surgery or endovascular 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
(Active Comparator)
rehabilitation with medical therapy
conservative treatment rehabilitation with medical therapy
rehabilitation with medical therapy

Primary Outcomes

Measure
Post-treatment improvement of peripheral artery disease
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 18-70 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.