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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Invasive treatment; Other: Conservative treatment

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Hsiang Juan, MD; Phone Number: +886-9-753-66388; Email: Jonat126@yahoo.com.tw

Study Locations

• Taiwan
  • Taoyuan
    • Gueishan, Taoyuan, Taiwan, 333
      • Recruiting
      • Chang Gung Memorial Hospital
      • Contact: Yu-Hsiang Juan, MD; Phone Number: +886-9-75366388; Email: Jonat126@yahoo.com.tw
      • Principal Investigator: Yu-Hsiang Juan, MD
      • Sub-Investigator: Yu-Ching Lin, MD
      • Sub-Investigator: Chun-Chin Chang
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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; Other Names: Surgery or endovascular treatment
Active Comparator: Conservative treatment; rehabilitation with medical therapy	Other: Conservative treatment; rehabilitation with medical therapy; Other Names: rehabilitation with medical therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yu-Hsiang Juan, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Cardiac function; Peripheral artery disease; Extracellular volume matrix fraction; Blood-oxygen level dependent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CMRPG3F1311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have to see if this corresponds to the IRB regulation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No