Clinical trial NCT02689414: A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Peripheral Artery Disease
Carotid Artery Stenosis
Keywords: Atherosclerosis
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Carotide-femoral pulse velocity
timeFrame: 24 h
measure: Augmentation index
timeFrame: 24 h
Secondary outcomes:
measure: Cardiac markers
timeFrame: 24 h
measure: Traditional biomarkers of renal function
timeFrame: 24 h
measure: Markers of inflammation and oxidative stress
timeFrame: 24 h
measure: Duration of hospital stay
timeFrame: 30 days
measure: Duration of intesive care unit stay
timeFrame: 30 days
measure: Cardiac event
timeFrame: 10 days
measure: Postoperative complications
timeFrame: 10 days
measure: 1- year mortality
timeFrame: 1 year
measure: Complications of remote ishcaemic preconditioning
timeFrame: 10 days
measure: Novel biomarkers of renal function
timeFrame: 24 h
measure: Estimated glomerular filtration rate
timeFrame: 24 h
measure: Low molecular-weight metabolites
timeFrame: 24 h
measure: Arterial elasticity indices
timeFrame: 24 h
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartu County
Study officials:
affiliation: Tartu University Hospital
name: Urmas Lepner, MD-PhD
role: STUDY_CHAIR
affiliation: Tartu University Hospital
name: Joel Starkopf, MD-PhD
role: STUDY_CHAIR
affiliation: University of Tartu
name: Mihkel Zilmer, MD-PhD
role: STUDY_CHAIR
affiliation: Tartu University Hospital
name: Jaak Kals, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tartu
name: Karl Kuusik, MD
role: STUDY_CHAIR
affiliation: University of Tartu
name: Teele Kepler, MD
role: STUDY_DIRECTOR
References:
citation: Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote ischaemic preconditioning influences the levels of acylcarnitines in vascular surgery: a randomised clinical trial. Nutr Metab (Lond). 2020 Sep 18;17:76. doi: 10.1186/s12986-020-00495-3. eCollection 2020.
citation: Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote Ischaemic Preconditioning Reduces Kidney Injury Biomarkers in Patients Undergoing Open Surgical Lower Limb Revascularisation: A Randomised Trial. Oxid Med Cell Longev. 2020 Jan 23;2020:7098505. doi: 10.1155/2020/7098505. eCollection 2020.
citation: Kepler T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Lieberg J, Vahi M, Kals J. The Effect of Remote Ischaemic Preconditioning on Arterial Stiffness in Patients Undergoing Vascular Surgery: A Randomised Clinical Trial. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):868-875. doi: 10.1016/j.ejvs.2018.12.002. Epub 2019 May 22.