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

NCT ID: NCT03466125

Last Updated: 2023-02-08

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

UNKNOWN

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Stroke, Acute Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Cardiac surgery

Intervention Type PROCEDURE

Retrospective cohort study

Interventions

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Cardiac surgery

Retrospective cohort study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Baystate Medical Center

OTHER

Sponsor Role collaborator

Cape Cod Hospital

OTHER

Sponsor Role collaborator

Mount Auburn Hospital

OTHER

Sponsor Role collaborator

Memorial University Medical Center

OTHER

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role collaborator

St. Elizabeth's Medical Center

UNKNOWN

Sponsor Role collaborator

SouthCoast Medical Group

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jochen Daniel Muehlschlegel, MD

Vice Chair of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen D Muehlschlegel, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jochen D Muehlschlegel, MD, MMSc

Role: CONTACT

617-732-7330

Facility Contacts

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Jochen D Muehlschlegel, MD, MMSc

Role: primary

617-525-8156

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017P002261

Identifier Type: -

Identifier Source: org_study_id

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