Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages - Full Text View

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

This study is enrolling participants by invitation only.

First Received: July 8, 2008 No Changes Posted

Sponsors and Collaborators:	GE Healthcare Turku University Hospital University of Turku Finnish Funding Agency for Technology and Innovation
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00712946

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	125
Study Start Date:	March 2006

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

Finnish Funding Agency for Technology and Innovation

Investigators

Principal Investigator:	Timo Laitio, MD, PhD	Turku University Hospital
Study Director:	Pekka Meriläinen, Prof.	GE Healthcare, Finland

More Information

No publications provided

Responsible Party:	Department of Anesthesiology and Intensive Care, Turku University Hospital ( Dr. Timo Laitio (Timo.Laitio@tyks.fi) )
Study ID Numbers:	M1155457
Study First Received:	July 8, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712946 History of Changes
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Arterial Occlusive Diseases
Arteriosclerosis Obliterans
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Arteriosclerosis Obliterans
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on May 07, 2009