A Study on the Phenomenon of Remote Ischaemic Preconditioning in Patients With Peripheral Artery Disease
1 other identifier
interventional
42
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2023
CompletedOctober 10, 2023
October 1, 2023
1.2 years
September 21, 2021
October 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Total Walking Distance at 28 Days
Maximal walking distance performed on a treadmill test
28 days
Secondary Outcomes (9)
Change from Baseline Initial Claudication Distance at 28 Days
28 days
Change from Baseline Time to Relief of Claudication at 28 Days
28 days
Change from Baseline Carotid-Femoral Pulse Wave Velocity at 28 Days
28 days
Change from Baseline Augmentation Index at 28 Days
28 days
Change from Baseline Low Molecular Weight Metabolite Levels in Serum at 28 Days
28 days
- +4 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTAL20 patients with PAD and claudication
Control group (sham)
SHAM COMPARATOR20 patients with PAD and claudication
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Peripheral arterial disease, which causes claudication
- Patients who have given written informed consent and are undergoing conservative treatment for claudication (continuous treatment for at least three months)
- Patients with lower limb atherosclerosis Fontaine class IIA or IIB
- The primary limiter of walking is claudication, not any other condition
- Ankle-brachial index (ABI) ≤ 0,9 in symptomatic lower limb
You may not qualify if:
- Female gender
- Resting blood pressure \> 200 mmHg
- Fontaine class III or IV
- eGFR \< 30 ml/min/1,73 m2
- Home oxygen therapy or severe COPD (GOLD 3-4)
- Heart failure NYHA III-IV
- Stable angina pectoris
- Clinically severe COVID-19 infection in the last three months
- History of malignancy (within the last five years)
- Persistent or permanent atrial fibrillation or flutter
- Acute myocardial infarction in the last three months
- Residual signs of cerebral infarction that impede movement
- Significant atherosclerosis of peripheral arteries of the upper limb (symptomatic)
- History of deep vein thrombosis of the upper limb
- Diabetic polyneuropathy
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tartu University Hospital
Tartu, Estonia
Related Publications (2)
Eerik K, Kasepalu T, Post H, Eha J, Kals M, Bjorck M, Kals J. Effects of Repeated Remote Ischaemic Preconditioning on Arterial Stiffness, Organ Damage, and Oxidative Stress in Patients with Intermittent Claudication: A Sham Controlled Randomised Trial. Eur J Vasc Endovasc Surg. 2025 Jun 24:S1078-5884(25)00575-1. doi: 10.1016/j.ejvs.2025.06.046. Online ahead of print.
PMID: 40571146DERIVEDEerik K, Kasepalu T, Post H, Eha J, Kals M, Kals J. Editor's Choice - Daily Remote Ischaemic Preconditioning for Intermittent Claudication: A Sham Controlled Randomised Trial. Eur J Vasc Endovasc Surg. 2025 Feb;69(2):295-302. doi: 10.1016/j.ejvs.2024.10.047. Epub 2024 Nov 8.
PMID: 39522584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaak Kals, PhD
University of Tartu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 19, 2021
Study Start
January 24, 2022
Primary Completion
April 18, 2023
Study Completion
April 18, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share