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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Invasive treatment
Conservative treatment
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Invasive treatment

Conservative treatment

Arm Description

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

rehabilitation with medical therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2016
Last Updated
April 6, 2017
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02850432
Brief Title
Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
Acronym
CMRPADDM
Official Title
The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Invasive treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
rehabilitation with medical therapy
Intervention Type
Procedure
Intervention Name(s)
Invasive treatment
Other Intervention Name(s)
Surgery or endovascular treatment
Intervention Description
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
Other
Intervention Name(s)
Conservative treatment
Other Intervention Name(s)
rehabilitation with medical therapy
Intervention Description
rehabilitation with medical therapy
Primary Outcome Measure Information:
Title
Post-treatment improvement of peripheral artery disease
Description
To determine the combined benefit of clinical and MRI imaging parameters (cardiac and lower extremities) in treatment response monitoring and treatment outcome prediction.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria include: Able to understand and provide signed informed consent DM history of 10 years and above Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable Willing to receive standard therapy such as surgery or medication Age between 18-80 years old The exclusion criteria include: Pregnant or breast-feeding women Allergic MRI contrast medium Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium). Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility Patients having dialysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsiang Juan, MD
Phone
+886-9-753-66388
Email
Jonat126@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Juan, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Gueishan
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Juan, MD
Phone
+886-9-75366388
Email
Jonat126@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Juan, MD
First Name & Middle Initial & Last Name & Degree
Yu-Ching Lin, MD
First Name & Middle Initial & Last Name & Degree
Chun-Chin Chang
First Name & Middle Initial & Last Name & Degree
Chen-Ming Sung
First Name & Middle Initial & Last Name & Degree
Jiun-jie Wang, PhD
First Name & Middle Initial & Last Name & Degree
Gigin Lin, MD
First Name & Middle Initial & Last Name & Degree
Yun-Chung Cheung, MD
First Name & Middle Initial & Last Name & Degree
Shu-Hang Ng, MD
First Name & Middle Initial & Last Name & Degree
Koon-Kwan Ng, MD
First Name & Middle Initial & Last Name & Degree
Jim Wu, MD
First Name & Middle Initial & Last Name & Degree
Yu-Chun Lin

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have to see if this corresponds to the IRB regulation.

Learn more about this trial

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

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