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Postoperative Atrial Fibrillation and Long-term Survival (POAF)

Primary Purpose

Death, Stroke, Myocardial Infarction

Status

Completed

Phase

Locations

Study Type

Observational

Intervention

About this trial

This is an observational trial for Death focused on measuring Atrial fibrillation, CABG, Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

previously cardiac operation, CABG or AVR

Exclusion Criteria:

Previous Atrial fibrillation

Sites / Locations

Outcomes

Primary Outcome Measures

cardiovascular and all-cause death

stroke

late atrial fibrillation

myocardial infarction

Secondary Outcome Measures

Full Information

NCT ID

NCT02349269

First Posted

December 1, 2014

Last Updated

January 23, 2015

Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

1. Study Identification

Unique Protocol Identification Number

NCT02349269

Brief Title

Postoperative Atrial Fibrillation and Long-term Survival

Acronym

POAF

Official Title

Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients

Study Type

Observational

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.

Detailed Description

The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances. Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Death, Stroke, Myocardial Infarction

Keywords

Atrial fibrillation, CABG, Stroke

7. Study Design

Enrollment

519 (Actual)

Target Follow-Up Duration

105 Months

Primary Outcome Measure Information:

Title

cardiovascular and all-cause death

Time Frame

1-105 month

Title

stroke

Time Frame

1-105 month

Title

late atrial fibrillation

Time Frame

1-105 month

Title

myocardial infarction

Time Frame

1-105 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: previously cardiac operation, CABG or AVR Exclusion Criteria: Previous Atrial fibrillation

Study Population Description

patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously

Sampling Method

Non-Probability Sample

12. IPD Sharing Statement

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Postoperative Atrial Fibrillation and Long-term Survival

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