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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712946
First Posted: July 10, 2008
Last Update Posted: April 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Turku University Hospital
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by:
GE Healthcare
July 8, 2008
July 10, 2008
April 28, 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

*   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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00712946
M1155457
Yes
Not Provided
Not Provided
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