CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Remote Ischemic Preconditioning +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02273232
NCT02273232Phase 1Completed

Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial

National University of Ireland, Galway, Ireland·interventional·Posted Oct 23, 2014·Updated Sep 25, 2017

In Brief

A Phase 1 clinical trial evaluating Remote Ischemic Preconditioning, Supervised Exercise, and 1 other intervention for Peripheral Arterial Diseases. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far. No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement. The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end. The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 23, 2014
Enrollment StartJan 1, 2015
Primary CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.7 years ago

Interventions

Remote Ischemic Preconditioningother

Blood pressure cuff will be inflated to 200 mmhg for 5 minuets and release for 5 minuets to total of 4 cycles

Supervised Exerciseother

constructed extra excessive for peripheral vascular diastase patients

Standard Careother

Standard Care for peripheral vascular disease patients including advises regarding exercises