Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
Barosleep
1 other identifier
observational
103
1 country
1
Brief 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. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 28, 2011
March 1, 2010
July 8, 2008
April 27, 2011
Conditions
Study Arms (2)
1
Arteriosclerosis obliterans patients undergoing elective vascular surgery
2
Healthy age-matched volunteers
Eligibility Criteria
ASO patients admitted to electrive vascualr surgery in Turku University Hospital
You may qualify if:
- Age \> 40 years
- ASO
- Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
- Turku University Hospitalcollaborator
- University of Turkucollaborator
- The Finnish Funding Agency for Technology and Innovation (TEKES)collaborator
Study Sites (1)
Department of Anesthesiology and Intensive Care, Turku University Hospital
Turku, Finland
Related Publications (3)
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.
PMID: 25544158DERIVEDUtriainen 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.
PMID: 24558173DERIVEDUtriainen 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.
PMID: 22700841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timo Laitio, MD, PhD
Turku University Hospital
- STUDY DIRECTOR
Pekka Meriläinen, Prof.
GE Healthcare, Finland
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2008
First Posted
July 10, 2008
Study Start
March 1, 2006
Study Completion
December 1, 2010
Last Updated
April 28, 2011
Record last verified: 2010-03