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A Study on the Phenomenon of Remote Ischaemic Preconditioning in Patients With Peripheral Artery Disease

NCT05084066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-10-10

No results posted yet for this study

Summary

This study aims to evaluate whether remote ischemic preconditioning (RIPC) daily for 28 days reduces the symptoms of intermittent claudication in patients with peripheral artery disease (PAD). The study evaluates the effect of RIPC on patients' total walking distance (TWC), initial claudication distance (ICD), and time to relief of claudication (TRC). In addition, the trial investigates the effect of RIPC on different arterial functional characteristics and low molecular weight metabolites in serum and affected skeletal muscle.

Conditions

  • Peripheral Arterial Disease

Interventions

OTHER

Repeated remote ischemic preconditioning

An automated device performs four 5-minute episodes of upper limb ischemia in which the cuff pressure in the experimental group remains at 200 mmHg for 5 minutes, causing and ensuring ischemia. Ischemic episodes alternate with 5-minute reperfusion. The intervention lasts a total of 35 minutes. The participant places the device on his upper arm and presses the "Start" button, starting the intervention. The intervention takes place at rest in the patient's home environment daily for 28 days. During the first visit to the research center, the research assistant teaches the participant how to use the device. The device measures the patient's blood pressure at the start of the intervention. If the patient's blood pressure is above 200 mmHg, the device will not perform the intervention.

OTHER

Simulation of repeated remote ischemic preconditioning (sham)

The automated device simulates the intervention of the experimental group with the difference that the device does not apply pressure to the upper limb and, therefore, no ischemia occurs.

Sponsors & Collaborators

  • Tartu University Hospital

    lead OTHER

Principal Investigators

  • Jaak Kals, PhD · University of Tartu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2023-04-18
Completion
2023-04-18

Countries

  • Estonia

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 NCT05084066 on ClinicalTrials.gov