Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages (Barosleep)

This study has been completed.
Sponsor:
Collaborators:
Turku University Hospital
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00712946
First received: July 8, 2008
Last updated: April 27, 2011
Last verified: March 2010

July 8, 2008
April 27, 2011
March 2006
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Complete list of historical versions of study NCT00712946 on ClinicalTrials.gov Archive Site
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Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

ASO patients admitted to electrive vascualr surgery in Turku University Hospital

Arteriosclerosis Obliterans
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  • 1
    Arteriosclerosis obliterans patients undergoing elective vascular surgery
  • 2
    Healthy age-matched volunteers
Utriainen KT, Airaksinen JK, Polo O, Raitakari OT, Pietilä 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2010
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Inclusion Criteria:

  • Age > 40 years
  • ASO
  • Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)

Exclusion Criteria:

  • 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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00712946
M1155457
Yes
Dr. Timo Laitio (Timo.Laitio@tyks.fi), Department of Anesthesiology and Intensive Care, Turku University Hospital
GE Healthcare
  • Turku University Hospital
  • University of Turku
  • The Finnish Funding Agency for Technology and Innovation (TEKES)
Principal Investigator: Timo Laitio, MD, PhD Turku University Hospital
Study Director: Pekka Meriläinen, Prof. GE Healthcare, Finland
GE Healthcare
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP