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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: |
NCT02406131 |
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Date of registration:
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19/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty
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Scientific title:
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Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty: A Pilot Randomized Control Trial |
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Date of first enrolment:
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April 2018 |
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Target sample size:
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40 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/show/NCT02406131 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Stewart Walsh, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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NUIGalway - UCHG |
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Key inclusion & exclusion criteria
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Inclusion criteria
1. Patients planned for lower limb Angioplasty
Exclusion criteria
1. Known upper limb PVD
2. Previous history of upper limb deep vein thrombosis
3. Patients on glibenclamide or nicorandil- May affect RIPC
4. Raynaud's Disease
5. Intra operative decision to use graft - will be documented
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Vascular Diseases
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Intervention(s)
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Other: Remote Ischemic Preconditioning
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Primary Outcome(s)
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Changes in inflammatory and coagulation markers comparing the 2 groups
[Time Frame: 24 hours post procedure]
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Restenosis
[Time Frame: 6 months post procedure]
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Secondary Outcome(s)
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Minor amputations
[Time Frame: 6 months post procedure]
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Percentage changes in ABI
[Time Frame: 6 months post procedure]
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Limb Amputation
[Time Frame: 6 months post procedure]
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Progression of Rutherford classification
[Time Frame: 6 months post procedure]
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Ulcer formation/ healing
[Time Frame: 6 months post procedure]
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Secondary ID(s)
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C.A. 1238
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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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