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

April 27, 2011 updated by: GE Healthcare
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Department of Anesthesiology and Intensive Care, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ASO patients admitted to electrive vascualr surgery in Turku University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (ESTIMATE)

July 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1155457

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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