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

Sponsor
GE Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT00712946
Collaborator
Turku University Hospital (Other), University of Turku (Other), The Finnish Funding Agency for Technology and Innovation (TEKES) (Other)
103
Enrollment
1
Location
57
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 1, 2006
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Arteriosclerosis obliterans patients undergoing elective vascular surgery
    2

    Healthy age-matched volunteers

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00712946
      Other Study ID Numbers:
      • M1155457
      First Posted:
      Jul 10, 2008
      Last Update Posted:
      Apr 28, 2011
      Last Verified:
      Mar 1, 2010
      Additional relevant MeSH terms:
      Arteriosclerosis
      Arteriosclerosis Obliterans

      Study Results

      No Results Posted as of Apr 28, 2011