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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02850432 |
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Date of registration:
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25/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
CMRPADDM |
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Scientific title:
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The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM |
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Date of first enrolment:
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May 1, 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02850432 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yu-Hsiang Juan, MD |
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Address:
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Telephone:
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+886-9-753-66388 |
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Email:
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Jonat126@yahoo.com.tw |
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Affiliation:
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Name:
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Yu-Hsiang Juan, MD |
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Address:
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Telephone:
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+886-9-75366388 |
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Email:
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Jonat126@yahoo.com.tw |
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Affiliation:
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Name:
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Yu-Hsiang Juan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Arterial Disease
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Intervention(s)
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Other: Conservative treatment
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Procedure: Invasive treatment
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Primary Outcome(s)
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Post-treatment improvement of peripheral artery disease
[Time Frame: 2 years]
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Secondary ID(s)
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CMRPG3F1311
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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