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

Peripheral Arterial Disease Clinical Trial

— CMRPADDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850432
• Other study ID #: CMRPG3F1311
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: April 6, 2017
• Start date: May 1, 2016
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2017
• Source: Chang Gung Memorial Hospital
• Contact: Yu-Hsiang Juan, MD
• Phone: +886-9-753-66388
• Email: Jonat126[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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:
• Conservative treatment
rehabilitation with medical therapy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Gueishan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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