Obstructive Sleep ApneaNCT04630535
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
An observational study of Obstructive Sleep Apnea and Vascular Aneurysm, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Vascular Aneurysm, Ischemia Reperfusion Injury
- What is being tested?
- aorto-bifemoral bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2020to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Who may be able to join
- patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Who cannot join
- emergent surgery
- aorto-bifemoral bypass using deep vein graft
- re-operations
- known OSA with CPAP treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
St. Anne's University Hospital Brno
Brno, Czech Republic, 65691
Ivan Cundrle, M.D., Ph.D., 00420543182553, ivan.cundrle@fnusa.cz
Marek Lukes, M.D., 00420543182553, marek.lukes@fnusa.cz
About this study
Official title: Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery
Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.
Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.
The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.
Read the detailed description
Patients. Consecutive patients scheduled for elective aortobifemoral bypass (AAA and Leriche syndrome patients) will be recruited for this prospective, observational study.
Polygraphy (PG). PG measurements will be done two nights before surgery using the Embletta system (Embla - Embletta MPR PG Sleep Data Recording System).
STOP-BANG, Epworth questionnaire. Both questionnaires will be done the same day as polygraphy
Cardiovascular complications will be assessed from the first 30 post-operative days Pulmonary complications will be assessed from the first 30 post-operative days
Specific markers of I/R. T0 - before anesthesia induction T1 - 3 hrs after aorta de-clamping T2 - 12 hrs after aorta de-clamping T3 - 24 hrs after aorta de-clamping T4 - on the fifth post-operative day
- Being tested
- aorto-bifemoral bypass surgery
- Keywords
- remote preconditioning
- Medical subject headings
- Sleep Apnea, Obstructive, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aorto-bifemoral bypass surgeryProcedure or surgery
aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass Receives: Procedure: aorto-bifemoral bypass surgery | |
| Without Obstructive Sleep Apnea | Patinets without OSA undergoing aorto-bifemoral bypass Receives: Procedure: aorto-bifemoral bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of I/R injury markers
Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration
Measured: T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day
Secondary outcomes (1)
post-operative complications
cardiovascular and pulmonary post-operative complications
Measured: up to 30 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Ivan Cundrle, M.D., Ph.D., Principal investigator, St. Anne's University Hospital in Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630535
- Sponsor's protocol ID
- IIT/2019/25
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katseni K, Chalkias A, Kotsis T, Dafnios N, Arapoglou V, Kaparos G, Logothetis E, Iacovidou N, Karvouni E, Katsenis K. The Effect of Perioperative Ischemia and Reperfusion on Multiorgan Dysfunction following Abdominal Aortic Aneurysm Repair. Biomed Res Int. 2015;2015:598980. doi: 10.1155/2015/598980. Epub 2015 Dec 21.
PubMed 26798637Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
PubMed 3769170Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME. Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial. J Endovasc Ther. 2009 Dec;16(6):680-9. doi: 10.1583/09-2817.1.
PubMed 19995115Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
PubMed 20484066Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y, Huang CY, Huang WQ, Liu KX. Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology. 2013 Apr;118(4):842-52. doi: 10.1097/ALN.0b013e3182850da5.
PubMed 23353795Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S, Boylan J, Conlon N. Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1285-92. doi: 10.1053/j.jvca.2014.04.018.
PubMed 25281045Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J, Yagoub H, Bashar K, O'Donnell M, Newell J, Canning C, McMonagle M, Dowdall J, Cross S, O'Daly S, Manning B, Fulton G, Kavanagh EG, Burke P, Grace PA, Moloney MC, Walsh SR; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery. Vasc Endovascular Surg. 2015 Nov;49(8):220-7. doi: 10.1177/1538574415614404. Epub 2015 Nov 16.
PubMed 26574485Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.
PubMed 27688236Thomas KN, Cotter JD, Williams MJ, van Rij AM. Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016 Apr;50(3):140-6. doi: 10.1177/1538574416639150. Epub 2016 Apr 12.
PubMed 27075990Mouton R, Pollock J, Soar J, Mitchell DC, Rogers CA. Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial. Trials. 2015 Aug 25;16:377. doi: 10.1186/s13063-015-0899-3.
PubMed 26303818De Freitas S, Hicks CW, Mouton R, Garcia S, Healy D, Connolly C, Thomas KN, Walsh SR. Effects of Ischemic Preconditioning on Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-analysis. J Surg Res. 2019 Mar;235:340-349. doi: 10.1016/j.jss.2018.09.049. Epub 2018 Nov 13.
PubMed 30691816Sanchez-de-la-Torre A, Soler X, Barbe F, Flores M, Maisel A, Malhotra A, Rue M, Bertran S, Aldoma A, Worner F, Valls J, Lee CH, Turino C, Galera E, de Batlle J, Sanchez-de-la-Torre M; Spanish Sleep Network( *). Cardiac Troponin Values in Patients With Acute Coronary Syndrome and Sleep Apnea: A Pilot Study. Chest. 2018 Feb;153(2):329-338. doi: 10.1016/j.chest.2017.06.046. Epub 2017 Jul 20.
PubMed 28736306Shah N, Redline S, Yaggi HK, Wu R, Zhao CG, Ostfeld R, Menegus M, Tracy D, Brush E, Appel WD, Kaplan RC. Obstructive sleep apnea and acute myocardial infarction severity: ischemic preconditioning? Sleep Breath. 2013 May;17(2):819-26. doi: 10.1007/s11325-012-0770-7. Epub 2012 Oct 23.
PubMed 23090861
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery
- ClinicalTrials.gov ID
- NCT04630535
- Acronym / sponsor ID
- IIT/2019/25
- Keywords
- remote preconditioning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 16 Nov 2020 (actual)
- 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.
Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.
Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.
The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.
Detailed description
Patients. Consecutive patients scheduled for elective aortobifemoral bypass (AAA and Leriche syndrome patients) will be recruited for this prospective, observational study.
Polygraphy (PG). PG measurements will be done two nights before surgery using the Embletta system (Embla - Embletta MPR PG Sleep Data Recording System).
STOP-BANG, Epworth questionnaire. Both questionnaires will be done the same day as polygraphy
Cardiovascular complications will be assessed from the first 30 post-operative days Pulmonary complications will be assessed from the first 30 post-operative days
Specific markers of I/R. T0 - before anesthesia induction T1 - 3 hrs after aorta de-clamping T2 - 12 hrs after aorta de-clamping T3 - 24 hrs after aorta de-clamping T4 - on the fifth post-operative day
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | Procedure: aorto-bifemoral bypass surgeryPacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass |
| Without Obstructive Sleep Apnea | – | Procedure: aorto-bifemoral bypass surgeryPatinets without OSA undergoing aorto-bifemoral bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Key inclusion criteria (1 listed)
- patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Key exclusion criteria (4 listed)
- emergent surgery
- aorto-bifemoral bypass using deep vein graft
- re-operations
- known OSA with CPAP treatment
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 |
|---|---|---|
| aorto-bifemoral bypass surgeryaorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair) | Procedure or surgery | Obstructive Sleep Apnea, Without Obstructive Sleep Apnea |
Primary outcome
Change of I/R injury markers
Time frame: T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day
Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration
1 secondary outcome
post-operative complications
Time frame: up to 30 post-operative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 26798637Katseni K, Chalkias A, Kotsis T, Dafnios N, Arapoglou V, Kaparos G, Logothetis E, Iacovidou N, Karvouni E, Katsenis K. The Effect of Perioperative Ischemia and Reperfusion on Multiorgan Dysfunction following Abdominal Aortic Aneurysm Repair. Biomed Res Int. 2015;2015:598980. doi: 10.1155/2015/598980. Epub 2015 Dec 21.
- Background: PubMed 3769170Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
- Background: PubMed 19995115Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME. Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial. J Endovasc Ther. 2009 Dec;16(6):680-9. doi: 10.1583/09-2817.1.
- Background: PubMed 20484066Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
- Background: PubMed 23353795Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y, Huang CY, Huang WQ, Liu KX. Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology. 2013 Apr;118(4):842-52. doi: 10.1097/ALN.0b013e3182850da5.
- Background: PubMed 25281045Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S, Boylan J, Conlon N. Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1285-92. doi: 10.1053/j.jvca.2014.04.018.
- Background: PubMed 26574485Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J, Yagoub H, Bashar K, O'Donnell M, Newell J, Canning C, McMonagle M, Dowdall J, Cross S, O'Daly S, Manning B, Fulton G, Kavanagh EG, Burke P, Grace PA, Moloney MC, Walsh SR; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery. Vasc Endovascular Surg. 2015 Nov;49(8):220-7. doi: 10.1177/1538574415614404. Epub 2015 Nov 16.
- Background: PubMed 27688236Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.
- Background: PubMed 27075990Thomas KN, Cotter JD, Williams MJ, van Rij AM. Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016 Apr;50(3):140-6. doi: 10.1177/1538574416639150. Epub 2016 Apr 12.
- Background: PubMed 26303818Mouton R, Pollock J, Soar J, Mitchell DC, Rogers CA. Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial. Trials. 2015 Aug 25;16:377. doi: 10.1186/s13063-015-0899-3.
- Background: PubMed 30691816De Freitas S, Hicks CW, Mouton R, Garcia S, Healy D, Connolly C, Thomas KN, Walsh SR. Effects of Ischemic Preconditioning on Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-analysis. J Surg Res. 2019 Mar;235:340-349. doi: 10.1016/j.jss.2018.09.049. Epub 2018 Nov 13.
- Background: PubMed 28736306Sanchez-de-la-Torre A, Soler X, Barbe F, Flores M, Maisel A, Malhotra A, Rue M, Bertran S, Aldoma A, Worner F, Valls J, Lee CH, Turino C, Galera E, de Batlle J, Sanchez-de-la-Torre M; Spanish Sleep Network( *). Cardiac Troponin Values in Patients With Acute Coronary Syndrome and Sleep Apnea: A Pilot Study. Chest. 2018 Feb;153(2):329-338. doi: 10.1016/j.chest.2017.06.046. Epub 2017 Jul 20.
- Individual participant dataSharing planned: No
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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.
Ivan Cundrle, M.D., Ph.D. principal investigator
St. Anne's University Hospital in Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Vascular Aneurysm, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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 Czechia. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Cundrle, M.D., Ph.D. (00420543182553, ivan.cundrle@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of I/R injury markers (time frame: T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day). 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 NCT04630535, which also lists 13 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 27 Apr 2026.