Arteriosclerosis ObliteransBarosleepNCT00712946
Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
An observational study of Arteriosclerosis Obliterans, run by GE Healthcare at 1 site in Finland.
Trial summary
The goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis Obliterans
- How many people
- 103 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2006to Dec 2010
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASO patients admitted to electrive vascualr surgery in Turku University Hospital
Who may be able to join
- Age > 40 years
- ASO
- Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)
Who cannot join
- Other than sinus rhythm
- Lack of co-operation
- Major surgery less than 3 months preoperatively
- Sleep apnoea
- Dialysis treatment
- CABG less than 3 years earlier
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Anesthesiology and Intensive Care, Turku University Hospital
Turku
About this study
The goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.
- Conditions
- Arteriosclerosis Obliterans
- Medical subject headings
- Arteriosclerosis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Arteriosclerosis obliterans patients undergoing elective vascular surgery | |
| 2 | Healthy age-matched volunteers |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startMar 2006
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arteriosclerosis ObliteransStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital, University of Turku, The Finnish Funding Agency for Technology and Innovation
- Investigators
- Timo Laitio, MD, PhD, Principal investigator, Turku University HospitalPekka Meriläinen, Prof., Study director, GE Healthcare, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712946
- Sponsor's protocol ID
- M1155457
- Acronym
- Barosleep
- Status last verified
- Mar 2010
- First submitted
- 8 Jul 2008
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Virtanen S, Utriainen KT, Parkkola R, Airaksinen JK, Laitio R, Scheinin H, Hakovirta H, Laitio TT; BAROSLEEP Study Group. White matter damage of the brain is associated with poor outcome in vascular surgery patients with claudication: a pilot study. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):687-93. doi: 10.1016/j.ejvs.2014.08.025. Epub 2014 Oct 1.
PubMed 25544158Utriainen KT, Airaksinen JK, Polo O, Laitio R, Pietila MJ, Scheinin H, Vahlberg T, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Parkkola R, Virtanen S, Laitio TT. Sleep apnoea is associated with major cardiac events in peripheral arterial disease. Eur Respir J. 2014 Jun;43(6):1652-60. doi: 10.1183/09031936.00130913. Epub 2014 Feb 20.
PubMed 24558173Utriainen KT, Airaksinen JK, Polo O, Raitakari OT, Pietila MJ, Scheinin H, Helenius HY, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Salo TM, Laitio TT. Unrecognised obstructive sleep apnoea is common in severe peripheral arterial disease. Eur Respir J. 2013 Mar;41(3):616-20. doi: 10.1183/09031936.00227611. Epub 2012 Jun 14.
PubMed 22700841
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
- ClinicalTrials.gov ID
- NCT00712946
- Acronym / sponsor ID
- Barosleep / M1155457
- Conditions
- Arteriosclerosis Obliterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital, University of Turku, The Finnish Funding Agency for Technology and Innovation
- Study start
- Mar 2006
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jul 2008 (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 goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Arteriosclerosis obliterans patients undergoing elective vascular surgery |
| 2 | – | –Healthy age-matched volunteers |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASO patients admitted to electrive vascualr surgery in Turku University Hospital
Key inclusion criteria (3 listed)
- Age > 40 years
- ASO
- Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)
Key exclusion criteria (6 listed)
- Other than sinus rhythm
- Lack of co-operation
- Major surgery less than 3 months preoperatively
- Sleep apnoea
- Dialysis treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Apr 2011.
- Derived from this study: PubMed 25544158Virtanen S, Utriainen KT, Parkkola R, Airaksinen JK, Laitio R, Scheinin H, Hakovirta H, Laitio TT; BAROSLEEP Study Group. White matter damage of the brain is associated with poor outcome in vascular surgery patients with claudication: a pilot study. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):687-93. doi: 10.1016/j.ejvs.2014.08.025. Epub 2014 Oct 1.
- Derived from this study: PubMed 24558173Utriainen KT, Airaksinen JK, Polo O, Laitio R, Pietila MJ, Scheinin H, Vahlberg T, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Parkkola R, Virtanen S, Laitio TT. Sleep apnoea is associated with major cardiac events in peripheral arterial disease. Eur Respir J. 2014 Jun;43(6):1652-60. doi: 10.1183/09031936.00130913. Epub 2014 Feb 20.
- Derived from this study: PubMed 22700841Utriainen KT, Airaksinen JK, Polo O, Raitakari OT, Pietila MJ, Scheinin H, Helenius HY, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Salo TM, Laitio TT. Unrecognised obstructive sleep apnoea is common in severe peripheral arterial disease. Eur Respir J. 2013 Mar;41(3):616-20. doi: 10.1183/09031936.00227611. Epub 2012 Jun 14.
Related trials for Arteriosclerosis Obliterans
Recruiting
Construction and Empirical Research of a Risk Prediction Model for Preventing Lower Extremity Arteriosclerosis Obliterans in Diabetic Patients Based on the HAPA Model
Diabetes Mellitus, Peripheral Arterial Disease
RecruitingObservational study
Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
Arteriosclerosis Obliterans
RecruitingPhase 4
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Critical Limb Ischemia, Buerger's Disease
Enrolling by invitationObservational study
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
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.
Timo Laitio, MD, PhD principal investigator
Turku University Hospital
Pekka Meriläinen, Prof. study director
GE Healthcare, Finland
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 Arteriosclerosis Obliterans, run by GE Healthcare at 1 site in Finland.
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 3 inclusion and 6 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 Apr 2011. 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 Finland. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712946, which also lists 3 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 Apr 2011.