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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03466125
Collaborator
Beth Israel Deaconess Medical Center (Other), Massachusetts General Hospital (Other), Baystate Medical Center (Other), Cape Cod Hospital (Other), Mount Auburn Hospital (Other), Memorial University Medical Center (Other), Tufts Medical Center (Other), St. Elizabeth's Medical Center (Other), SouthCoast Medical Group (Other)
25,000
Enrollment
1
Location
83
Anticipated Duration (Months)
301.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiac surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
25000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Recurrent atrial fibrillation [Up to six years after surgery]

    Recurrent atrial fibrillation

  2. Acute ischemic stroke [Up to six years after surgery]

    Acute ischemic stroke

  3. Mortality [Up to six years after surgery]

    Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jochen D Muehlschlegel, MD, MMSc, Brigham and Women's Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jochen Daniel Muehlschlegel, MD, Vice Chair of Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03466125
Other Study ID Numbers:
  • 2017P002261
First Posted:
Mar 15, 2018
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Atrial Fibrillation

Study Results

No Results Posted as of May 11, 2021