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

Atrial Fibrillation Clinical Trial

— MATRICeS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466125
• Other study ID #: 2017P002261
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Jochen D Muehlschlegel, MD, MMSc
• Phone: 617-732-7330
• Email: jmuehlschlegel[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Death
• Stroke
• Stroke, Acute

Intervention

Procedure:
• Cardiac surgery
Retrospective cohort study

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (10)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Baystate Medical Center, Beth Israel Deaconess Medical Center, Cape Cod Hospital, Massachusetts General Hospital, Memorial University Medical Center, Mount Auburn Hospital, SouthCoast Medical Group, St. Elizabeth's Medical Center, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent atrial fibrillation	Recurrent atrial fibrillation	Up to six years after surgery
Primary	Acute ischemic stroke	Acute ischemic stroke	Up to six years after surgery
Primary	Mortality	Mortality	Up to six years after surgery