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

Arteriosclerosis Obliterans Clinical Trial

— Barosleep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712946
• Other study ID #: M1155457
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: April 27, 2011
• Start date: March 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans

Locations

Country	Name	City	State
Finland	Department of Anesthesiology and Intensive Care, Turku University Hospital	Turku

Sponsors (4)

Lead Sponsor	Collaborator
GE Healthcare	The Finnish Funding Agency for Technology and Innovation (TEKES), Turku University Hospital, University of Turku

Country where clinical trial is conducted

Finland,