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

General Electric (GE)

Status: Completed

Conditions: Arteriosclerosis Obliterans

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00712946

M1155457

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

1

Description:

Arteriosclerosis obliterans patients undergoing elective vascular surgery

2

Description:

Healthy age-matched volunteers