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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:
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
History of Changes
  Purpose

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
Arteriosclerosis Obliterans

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages

Further study details as provided by GE Healthcare:

Enrollment: 103
Study Start Date: March 2006
Study Completion Date: December 2010
Groups/Cohorts
1
Arteriosclerosis obliterans patients undergoing elective vascular surgery
2
Healthy age-matched volunteers

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by GE Healthcare

Additional 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
Study First Received: July 8, 2008
Last Updated: April 27, 2011
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on May 23, 2013