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

T

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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