Peripheral Vascular Disease Clinical Trial
Official title:
Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty
This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal protection in patients undergoing peripheral angioplasty. Patients will be randomised to receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if any protective benefit was obtained.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Elective intra-arterial, infrainguinal peripheral angiography/angioplasty - Written informed consent - Patients >18yrs of age - Patients with CKD (Stage2/3) as evidenced by eGFR <90ml/min/1.73m2 Exclusion Criteria: - Severe renal impairment eGFR <30ml/min - Evidence of acute renal failure or patients on dialysis - History of previous CIN - Contraindication to intravenous volume replacement therapy - Pregnancy - Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | HSE Mid Western Regional Hospital | Limerick |
Lead Sponsor | Collaborator |
---|---|
Mid Western Regional Hospital, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal impairment | Serial assessment of renal biomarkers in serum and urine in 72 hour period post procedure | 72 hours post procedural | No |
Secondary | Anti-inflammatory effect of RIPC | Assessment of additional postulated benefits of anti-inflammatory effects with RIPC in terms of decreased restenosis rates and lower inflammatory markers | 3-6 months post recruitment | No |
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