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

Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)

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.

Study Overview

• Status: Recruiting
• Conditions: Death; Atrial Fibrillation; Stroke, Acute
• Intervention / Treatment: Procedure: Cardiac surgery

• Study Type: Observational
• Enrollment (Anticipated): 25000

Contacts and Locations

• Study Contact: Name: Jochen D Muehlschlegel, MD, MMSc; Phone Number: 617-732-7330; Email: jmuehlschlegel@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jochen D Muehlschlegel, MD, MMSc; Phone Number: 617-525-8156; Email: jmuehlschlegel@bwh.harvard.edu
      • Principal Investigator: Jochen D Muehlschlegel, MD, MMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Retrospective cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Tufts Medical Center; Baystate Medical Center; SouthCoast Medical Group; Cape Cod Hospital; Mount Auburn Hospital; Memorial University Medical Center; St. Elizabeth's Medical Center
• Investigators: Principal Investigator: Jochen D Muehlschlegel, MD, MMSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: 2017P002261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No