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

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Invasive treatment; Other: Conservative treatment

• Registration Number: NCT02850432
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-08-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Invasive treatment	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
Conservative treatment	Conservative treatment	rehabilitation with medical therapy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Gueishan, Taoyuan, Taiwan

Chang Gung Memorial Hospital

🇨🇳Gueishan, Taoyuan, Taiwan

Yu-Hsiang Juan, MD

Principal Investigator

Yu-Ching Lin, MD

Sub Investigator

Chun-Chin Chang

Sub Investigator

Chen-Ming Sung

Sub Investigator

Jiun-jie Wang, PhD

Sub Investigator

Gigin Lin, MD

Sub Investigator

Yun-Chung Cheung, MD

Sub Investigator

Shu-Hang Ng, MD

Sub Investigator

Koon-Kwan Ng, MD

Sub Investigator

Jim Wu, MD

Sub Investigator

Yu-Chun Lin

Sub Investigator