Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT03466125

Conditions

Atrial Fibrillation

Stroke, Acute

Death

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Cardiac surgery

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Stroke, Acute

Death

Study ID

NCT03466125

Start date

Jan 1, 2018

Status verified date

Feb, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

25000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiac surgery

Retrospective cohort study

Primary outcome measure

  • Recurrent atrial fibrillation [ Time Frame: Up to six years after surgery ]
  • Acute ischemic stroke [ Time Frame: Up to six years after surgery ]
  • Mortality [ Time Frame: Up to six years after surgery ]

Central Contacts and Locations

Central contacts

Jochen D Muehlschlegel, MD, MMSc

617-732-7330jmuehlschlegel@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jochen D Muehlschlegel, MD, MMSc

617-525-8156jmuehlschlegel@bwh.harvard.edu

Principal Investigator:

Jochen D Muehlschlegel, MD, MMSc

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-02-08.