NCT04193813

Brief Summary

There are a wide range of significant epidemiological, clinical, and operative predictors for the development of post-CABG AF including older age, female gender, large LA diameter, higher CHA2DS2-VASc score, valve replacement and postoperative inotropic support. Nevertheless, further large-scale studies are still needed to confirm our findings

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

December 7, 2019

Last Update Submit

May 26, 2020

Conditions

AF - Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of POAF

    Incidence of POAF 72hours postoperative

    6 months

Study Arms (2)

POAF

Other: Observational

Non POAF

Other: Observational

Interventions

ObservationalOTHER

Observational study

Non POAFPOAF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

You may qualify if:

  • Patients undergoing isolated CABG
  • Patients undergoing CABG with (Aortic and / or Mitral) valve replacement
  • age group between 18 and 70 years old.

You may not qualify if:

  • Patients diagnosed preoperatively with AF or have history of AF
  • Patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR)
  • Patients with impaired systolic function (Ejection fraction (EF) \< 30%)
  • Patients with end stage renal disease (ESRD) on hemodialysis
  • Patients who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 10, 2019

Study Start

May 15, 2018

Primary Completion

March 18, 2019

Study Completion

May 23, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)