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Status unknownNCT03466125MATRICeSUpdated Feb 8, 2023

Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery

An observational study in Atrial Fibrillation, Stroke, Acute and Death, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Brigham and Women's Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
25,000
Ages
20 Years to 99 Years
Sex
All
01

Study summary

The purpose of the research is to identify the frequency and severity of adverse events related to atrial fibrillation that occur after discharge from hospital where the patient underwent cardiac surgery.

The Specific Aims of the proposed study are to:

  1. Identify the predictors of postoperative atrial fibrillation after discharge from hospital.
  2. Identify the frequency of readmission to hospital, or other resource use such as Emergency Department or outpatient visit, for the treatment or prophylaxis of postoperative AF and consequent stroke or bleeding outcomes.
  3. Identify the risks for stroke, death and other morbidity in patients after cardiac surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.
02

Conditions studied

  • Atrial Fibrillation
  • Stroke, Acute
  • Death
03

Who can participate

Ages eligible
20 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Inclusion criteria

  • Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Exclusion criteria

Exclusion Criteria:

  • surgical procedures that do not include coronary artery bypass graft surgery, aortic valve surgery or mitral valve surgery;
  • surgical procedures that include MAZE surgery, or pulmonary vein isolation, ventricular assist device, heart transplantation, congenital heart surgery, bacterial endocarditis, cardiac trauma, cardiac tumor, ventricular septal defect repair, left ventricular aneurysm repair, pulmonary thromboendarterectomy, sub-aortic stenosis resection or surgical ventricular restoration;
  • surgical procedures on patients that have undergone MAZE surgery, AF ablation procedures, pulmonary vein isolation or left atrial appendage resection or ablation (such as Watchman devices).
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
25,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult patients who underwent cardiac surgery in Massachusetts

    No interventions. A retrospective cohort study of patients who underwent cardiac surgery in Massachusetts in calendar years 2012 - 2016.

    Procedure: Cardiac surgery

Interventions

  • ProcedureCardiac surgery

    Retrospective cohort study

05

What researchers measure

Primary outcomes

  1. Recurrent atrial fibrillation

    Recurrent atrial fibrillation

    Time frame: Up to six years after surgery

  2. Acute ischemic stroke

    Acute ischemic stroke

    Time frame: Up to six years after surgery

  3. Mortality

    Mortality

    Time frame: Up to six years after surgery

06

Study locations

1 of 1 sites recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
    • Jochen D Muehlschlegel, MD, MMSc · Contact · jmuehlschlegel@bwh.harvard.edu · 617-525-8156
    • Jochen D Muehlschlegel, MD, MMSc · Principal investigator
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03466125
Lead sponsor
Brigham and Women's Hospital
Collaborators
Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Baystate Medical Center, Cape Cod Hospital, Mount Auburn Hospital, Memorial University Medical Center, Tufts Medical Center, St. Elizabeth's Medical Center, SouthCoast Medical Group
Responsible party
Jochen Daniel Muehlschlegel, MD (Vice Chair of Research, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 15, 2018
Start date
Jan 1, 2018
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Feb 8, 2023

Study contacts

Jochen D Muehlschlegel, MD, MMSc
Contact
jmuehlschlegel@bwh.harvard.edu
617-732-7330
Jochen D Muehlschlegel, MD, MMSc
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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