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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

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.

Study Type

Interventional

Primary Outcome

Carotide-femoral pulse velocity

Secondary Outcome

 Cardiac markers

Condition

Abdominal Aortic Aneurysm

Intervention

Remote ischaemic preconditioning

Study Arms / Comparison Groups

 Remote ischaemic preconditioning
Description:  Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

98

Start Date

January 2016

Completion Date

February 2019

Primary Completion Date

February 8, 2018

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

          -  patients who are not able to follow the study regimen

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Urmas Lepner, MD-PhD, ,

Location Countries

Estonia

Location Countries

Estonia

Administrative Informations

NCT ID

NCT02689414

Organization ID

16004

Responsible Party

Principal Investigator

Study Sponsor

Tartu University Hospital

Study Sponsor

Urmas Lepner, MD-PhD, Study Chair, Tartu University Hospital

Verification Date

February 2018