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

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ClinicalTrials.gov Identifier: NCT00712946
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : April 28, 2011
Sponsor:
Collaborators:
Turku University Hospital
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by:
GE Healthcare

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.

Condition or disease
Arteriosclerosis Obliterans

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
Study Start Date : March 2006
Actual Study Completion Date : December 2010

Group/Cohort
1
Arteriosclerosis obliterans patients undergoing elective vascular surgery
2
Healthy age-matched volunteers




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ASO patients admitted to electrive vascualr surgery in Turku University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712946


Locations
Finland
Department of Anesthesiology and Intensive Care, Turku University Hospital
Turku, Finland
Sponsors and Collaborators
GE Healthcare
Turku University Hospital
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Principal Investigator: Timo Laitio, MD, PhD Turku University Hospital
Study Director: Pekka Meriläinen, Prof. GE Healthcare, Finland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Timo Laitio (Timo.Laitio@tyks.fi), Department of Anesthesiology and Intensive Care, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00712946     History of Changes
Other Study ID Numbers: M1155457
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: March 2010

Additional relevant MeSH terms:
Arteriosclerosis
Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases