NCT02349269

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

December 1, 2014

Last Update Submit

January 23, 2015

Conditions

DeathStrokeMyocardial Infarction

Keywords

Atrial fibrillationCABGStroke

Outcome Measures

Primary Outcomes (4)

  • cardiovascular and all-cause death

    1-105 month

  • stroke

    1-105 month

  • late atrial fibrillation

    1-105 month

  • myocardial infarction

    1-105 month

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • previously cardiac operation, CABG or AVR

You may not qualify if:

  • Previous Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DeathStrokeMyocardial InfarctionAtrial Fibrillation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaNecrosisArrhythmias, Cardiac

Study Design

Study Type
observational
Target Duration
105 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

January 28, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

September 1, 2014

Last Updated

January 28, 2015

Record last verified: 2014-11