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

NCT03466125 | Unknown

• 1 other identifier: 2017P002261
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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. 1.Identify the predictors of postoperative atrial fibrillation after discharge from hospital.
2. 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. 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

Outcome Measures

Primary Outcomes (3)

• Recurrent atrial fibrillation

  Recurrent atrial fibrillation

  Up to six years after surgery

• Acute ischemic stroke

  Acute ischemic stroke

  Up to six years after surgery

• Mortality

  Mortality

  Up to six years after surgery

Study Arms (1)

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

Cardiac surgery PROCEDURE

Retrospective cohort study

Adult patients who underwent cardiac surgery in Massachusetts

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator
• Baystate Medical Center: collaborator
• Cape Cod Hospital: collaborator
• Mount Auburn Hospital: collaborator
• Memorial University Medical Center: collaborator
• Tufts Medical Center: collaborator
• St. Elizabeth's Medical Center: collaborator
• SouthCoast Medical Group: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Death

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Jochen D Muehlschlegel, MD, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen D Muehlschlegel, MD, MMSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)