A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery

Tartu University Hospital

Status: Completed

Conditions: Carotid Artery Stenosis; Peripheral Artery Disease; Abdominal Aortic Aneurysm

Treatments: Procedure: Remote ischaemic preconditioning; Procedure: Control to RIPC

Study type: Interventional

Funder types: Other

Identifiers

NCT02689414

16004

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who are willing to give full informed consent for participation and
• who are undergoing open abdominal aortic aneurysm repair or
• who are undergoing endovascular aortic aneurysm repair or
• who are undergoing lower limb revascularization surgery or
• who are undergoing carotid endarterectomy

Exclusion criteria

• patients under age of 18
• patients who are pregnant
• patients with known malignancy during last 5 years
• patients with permanent atrial fibrillation or flutter
• patients with symptomatic upper limb atherosclerosis
• patients who require home oxygen therapy
• patients with eGFR < 30 ml/min/1.73 m2, measured preoperatively
• patients who have had myocardial infarction during last month
• patients who have had upper limb vein thrombosis
• patients who have undergone vascular surgery in the axillary region
• patients who are not able to follow the study regimen

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

Remote ischaemic preconditioning

Experimental group

Description:

Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.

Treatment:

Procedure: Remote ischaemic preconditioning

Control to RIPC

Sham Comparator group

Description:

Four episodes of 5 minutes during which the pressure in the cuff is equal to venous pressure are performed. Between all the episodes there is a 5-minute pause.

Treatment:

Procedure: Control to RIPC