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

NCT ID: NCT00712946

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arteriosclerosis Obliterans

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Arteriosclerosis obliterans patients undergoing elective vascular surgery

No interventions assigned to this group

2

Healthy age-matched volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

The Finnish Funding Agency for Technology and Innovation (TEKES)

OTHER_GOV

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Department of Anesthesiology and Intensive Care, Turku University Hospital

Principal Investigators

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Timo Laitio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Pekka Meriläinen, Prof.

Role: STUDY_DIRECTOR

GE Healthcare, Finland

Locations

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Department of Anesthesiology and Intensive Care, Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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Virtanen S, Utriainen KT, Parkkola R, Airaksinen JK, Laitio R, Scheinin H, Hakovirta H, Laitio TT; BAROSLEEP Study Group. White matter damage of the brain is associated with poor outcome in vascular surgery patients with claudication: a pilot study. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):687-93. doi: 10.1016/j.ejvs.2014.08.025. Epub 2014 Oct 1.

Reference Type DERIVED
PMID: 25544158 (View on PubMed)

Utriainen KT, Airaksinen JK, Polo O, Laitio R, Pietila MJ, Scheinin H, Vahlberg T, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Parkkola R, Virtanen S, Laitio TT. Sleep apnoea is associated with major cardiac events in peripheral arterial disease. Eur Respir J. 2014 Jun;43(6):1652-60. doi: 10.1183/09031936.00130913. Epub 2014 Feb 20.

Reference Type DERIVED
PMID: 24558173 (View on PubMed)

Utriainen KT, Airaksinen JK, Polo O, Raitakari OT, Pietila MJ, Scheinin H, Helenius HY, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Salo TM, Laitio TT. Unrecognised obstructive sleep apnoea is common in severe peripheral arterial disease. Eur Respir J. 2013 Mar;41(3):616-20. doi: 10.1183/09031936.00227611. Epub 2012 Jun 14.

Reference Type DERIVED
PMID: 22700841 (View on PubMed)

Other Identifiers

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M1155457

Identifier Type: -

Identifier Source: org_study_id

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