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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Conservative treatment | Active Comparator | rehabilitation with medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive treatment | Procedure | 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 |
| 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 |
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The inclusion criteria include:
The exclusion criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Hsiang Juan, MD | Contact | +886-9-753-66388 | Jonat126@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsiang Juan, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Guishan | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36651955 | Derived | 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. |
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We have to see if this corresponds to the IRB regulation.
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000072700 | Conservative Treatment |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Conservative treatment | Other | rehabilitation with medical therapy |
|
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |