NCT04630535 OSA as a Remote Ischemic Preconditioning in Vascular Surgery
| NCT ID | NCT04630535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Anne's University Hospital Brno, Czech Republic |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-11-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients) Exclusion Criteria: * emergent surgery * aorto-bifemoral bypass using deep vein graft * re-operations * known OSA with CPAP treatment
Contact & Investigator
Ivan Cundrle, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
St. Anne's University Hospital in Brno
Frequently Asked Questions
Who can join the NCT04630535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04630535 currently recruiting?
Yes, NCT04630535 is actively recruiting participants. Contact the research team at ivan.cundrle@fnusa.cz for enrollment information.
Where is the NCT04630535 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT04630535 clinical trial?
NCT04630535 is sponsored by St. Anne's University Hospital Brno, Czech Republic. The principal investigator is Ivan Cundrle, M.D., Ph.D. at St. Anne's University Hospital in Brno. The trial plans to enroll 100 participants.