Clinical trial NCT03466125: Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery
Official title: Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke, Acute
Death
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Baystate Medical Center
name: Cape Cod Hospital
name: Mount Auburn Hospital
name: Memorial University Medical Center
name: Tufts Medical Center
name: St. Elizabeth's Medical Center
name: SouthCoast Medical Group
First posted: 2018-03-15
Enrollment: 25000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Recurrent atrial fibrillation
timeFrame: Up to six years after surgery
measure: Acute ischemic stroke
timeFrame: Up to six years after surgery
measure: Mortality
timeFrame: Up to six years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jochen D Muehlschlegel, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: