Peripheral Arterial DiseaseCMRPADDMNCT02850432
Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
A study testing Invasive treatment and Conservative treatment in people with Peripheral Arterial Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Invasive treatment and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2016to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
Yu-Hsiang Juan, MD, +886-9-75366388, Jonat126@yahoo.com.tw
Yu-Hsiang Juan, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Invasive treatment, Conservative treatment
- Keywords
- Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive treatmentProcedure or surgery
Also called 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
Conservative treatmentOther
Also called rehabilitation with medical therapy
rehabilitation with medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Invasive treatment | 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 Receives: Procedure: Invasive treatment |
| Conservative treatment | Active comparator | rehabilitation with medical therapy Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start1 May 2016
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsiang Juan, Chang Gung Memorial Hospital
- Investigators
- Yu-Hsiang Juan, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850432
- Sponsor's protocol ID
- CMRPG3F1311
- Acronym
- CMRPADDM
- Status last verified
- Apr 2017
- First submitted
- 25 Jul 2016
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have to see if this corresponds to the IRB regulation.
Publications
Lin YC, Fu TC, Lin G, Ng SH, Yeh CH, Ng SC, Chang TC, Juan YH. Using T1 mapping indices to evaluate muscle function and predict conservative treatment outcomes in diabetic patients with peripheral arterial disease. Eur Radiol. 2023 Jul;33(7):4927-4937. doi: 10.1007/s00330-023-09392-8. Epub 2023 Jan 18.
PubMed 36651955
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
- ClinicalTrials.gov ID
- NCT02850432
- Acronym / sponsor ID
- CMRPADDM / CMRPG3F1311
- Conditions
- Peripheral Arterial Disease
- Keywords
- Magnetic resonance imaging, Extracellular volume matrix fraction, Peripheral artery disease, Blood-oxygen level dependent, Cardiac function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive treatment | Active comparator | Procedure: Invasive treatmentEndovascular 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 | Active comparator | Other: Conservative treatmentrehabilitation with medical therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive treatmentAlso: Surgery or endovascular treatmentEndovascular 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 or surgery | Invasive treatment |
| Conservative treatmentAlso: rehabilitation with medical therapyrehabilitation with medical therapy | Other | Conservative treatment |
Primary outcome
Post-treatment improvement of peripheral artery disease
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 36651955Lin YC, Fu TC, Lin G, Ng SH, Yeh CH, Ng SC, Chang TC, Juan YH. Using T1 mapping indices to evaluate muscle function and predict conservative treatment outcomes in diabetic patients with peripheral arterial disease. Eur Radiol. 2023 Jul;33(7):4927-4937. doi: 10.1007/s00330-023-09392-8. Epub 2023 Jan 18.
- Individual participant dataSharing planned: Undecided. We have to see if this corresponds to the IRB regulation.
Related trials for Peripheral Arterial Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsiang Juan, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive treatment and Conservative treatment in people with Peripheral Arterial Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsiang Juan, MD (+886-9-753-66388, Jonat126@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment improvement of peripheral artery disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02850432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.