Abdominal Aortic AneurysmNCT02689414
A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery
A study testing Remote ischaemic preconditioning in people with Abdominal Aortic Aneurysm and Peripheral Artery Disease, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Peripheral Artery Disease, Carotid Artery Stenosis
- What is being tested?
- Remote ischaemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteEstonia
- Study dates
- Jan 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Remote ischaemic preconditioning, Control to RIPC
- Keywords
- Atherosclerosis
- Medical subject headings
- Aortic Aneurysm, Abdominal, Peripheral Arterial Disease, Carotid Stenosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic preconditioningProcedure or surgery
Also called RIPC
Ischaemia is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 200 mm Hg or to a value that is 20 mm Hg greater than the patient's systolic blood pressure - if the patient's systolic blood pressure is more than 180 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.
Control to RIPCProcedure or surgery
Venous pressure is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 10-20 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischaemic preconditioning | Experimental | Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion. Receives: Procedure: Remote ischaemic preconditioning |
| Control to RIPC | Sham comparator | 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. Receives: Procedure: Control to RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotide-femoral pulse velocity
Measured with Sphygmocor XCEL
- baseline characteristics are measured before surgery
- measuring is repeated 24 h after surgery
Measured: 24 h
Augmentation index
Measured with Sphygmocor XCEL
- baseline characteristics are measured before surgery
- measuring is repeated 24 h after surgery
Measured: 24 h
Secondary outcomes (13)
Cardiac markers
Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).
Measured: 24 h
Traditional biomarkers of renal function
Creatinine, Urea
Measured: 24 h
Markers of inflammation and oxidative stress
Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.
Measured: 24 h
Duration of hospital stay
Measured: 30 days
Duration of intesive care unit stay
Measured: 30 days
Cardiac event
Myocardial infarction or cardiac arrest
Measured: 10 days
Postoperative complications
Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.
Measured: 10 days
1- year mortality
Measured: 1 year
Complications of remote ishcaemic preconditioning
Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.
Measured: 10 days
Novel biomarkers of renal function
Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M),
Measured: 24 h
Estimated glomerular filtration rate
eGFR
Measured: 24 h
Low molecular-weight metabolites
- Acylcarnitines
- Amino acids: leucine, ornithine, methionine, alanine, phenylalanine, valine, glutamate, tyrosine, glycine, arginine, citrulline, asparagine, aspartate, glutamine, histidine, lysine, proline, tryptophan, serine, threonine, cysteine and hydroxyproline.
- Hydroxy acids: citrate, α-oxoglutarate, pyruvate, succinate, mallonic acid, β-hydroxybutyrate, cis-aconitic acid and oxaloacetate.
Measured: 24 h
Arterial elasticity indices
Measured with HDI pulsewave CR-200
- baseline characteristics are measured before surgery
- measuring is repeated 24 h after surgery
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion8 Feb 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaak Kals, Tartu University Hospital
- Investigators
- Urmas Lepner, MD-PhD, Study chair, Tartu University HospitalJoel Starkopf, MD-PhD, Study chair, Tartu University HospitalMihkel Zilmer, MD-PhD, Study chair, University of TartuJaak Kals, MD-PhD, Principal investigator, Tartu University HospitalKarl Kuusik, MD, Study chair, University of TartuTeele Kepler, MD, Study director, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689414
- Sponsor's protocol ID
- 16004
- Status last verified
- Feb 2018
- First submitted
- 3 Feb 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
Publications
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250Kasepalu 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.
PubMed 32968425Kasepalu 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.
PubMed 32047578Kepler 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.
PubMed 31126835
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT02689414
- Acronym / sponsor ID
- 16004
- Keywords
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- Feb 2019
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischaemic preconditioning | Experimental | Procedure: Remote ischaemic preconditioningFour episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion. |
| Control to RIPC | Sham comparator | Procedure: Control to RIPCFour 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischaemic preconditioningAlso: RIPCIschaemia is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 200 mm Hg or to a value that is 20 mm Hg greater than the patient's systolic blood pressure - if the patient's systolic blood pressure is more than 180 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier. | Procedure or surgery | Remote ischaemic preconditioning |
| Control to RIPCVenous pressure is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 10-20 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier. | Procedure or surgery | Control to RIPC |
Primary outcome
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
13 secondary outcomes
Cardiac markers
Time frame: 24 h
Traditional biomarkers of renal function
Time frame: 24 h
Markers of inflammation and oxidative stress
Time frame: 24 h
Duration of hospital stay
Time frame: 30 days
Duration of intesive care unit stay
Time frame: 30 days
Cardiac event
Time frame: 10 days
Postoperative complications
Time frame: 10 days
1- year mortality
Time frame: 1 year
Complications of remote ishcaemic preconditioning
Time frame: 10 days
Novel biomarkers of renal function
Time frame: 24 h
Estimated glomerular filtration rate
Time frame: 24 h
Low molecular-weight metabolites
Time frame: 24 h
Arterial elasticity indices
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
- Derived from this study: PubMed 32968425Kasepalu 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.
- Derived from this study: PubMed 32047578Kasepalu 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.
- Derived from this study: PubMed 31126835Kepler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urmas Lepner, MD-PhD study chair
Tartu University Hospital
Joel Starkopf, MD-PhD study chair
Tartu University Hospital
Mihkel Zilmer, MD-PhD study chair
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic preconditioning in people with Abdominal Aortic Aneurysm and Peripheral Artery Disease, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotide-femoral pulse velocity (time frame: 24 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689414, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.