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

NCT02273232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-09-25

No results posted yet for this study

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

Conditions

  • Peripheral Arterial Diseases

Interventions

OTHER

Remote Ischemic Preconditioning

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

OTHER

Supervised Exercise

constructed extra excessive for peripheral vascular diastase patients

OTHER

Standard Care

Standard Care for peripheral vascular disease patients including advises regarding exercises

Sponsors & Collaborators

  • University College Hospital Galway

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Stewart E Walsh, Professor · NUIG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-05-05
Completion
2017-05-05

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273232 on ClinicalTrials.gov