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Clinical Trials/NCT02689414
NCT02689414
Completed
N/A

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

Tartu University Hospital1 site in 1 country98 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm
Sponsor
Tartu University Hospital
Enrollment
98
Locations
1
Primary Endpoint
Carotide-femoral pulse velocity
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaak Kals

Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD

Tartu University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Carotide-femoral pulse velocity

Time Frame: 24 h

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Augmentation index

Time Frame: 24 h

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Secondary Outcomes

  • Cardiac markers(24 h)
  • Traditional biomarkers of renal function(24 h)
  • Markers of inflammation and oxidative stress(24 h)
  • Duration of hospital stay(30 days)
  • Duration of intesive care unit stay(30 days)
  • Cardiac event(10 days)
  • Postoperative complications(10 days)
  • 1- year mortality(1 year)
  • Complications of remote ishcaemic preconditioning(10 days)
  • Novel biomarkers of renal function(24 h)
  • Estimated glomerular filtration rate(24 h)
  • Low molecular-weight metabolites(24 h)
  • Arterial elasticity indices(24 h)

Study Sites (1)

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