Characterization and Prediction of Atrial Fibrillation-ca... | NCT03466125

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

NCT03466125

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation
Stroke, Acute
Death

Interventions

Cardiac surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Mar 5, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jochen Daniel Muehlschlegel, MD, Vice Chair of Research, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
Beth Israel Deaconess Medical Center	OTHER
Massachusetts General Hospital	OTHER
Baystate Medical Center	OTHER
Cape Cod Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure	Retrospective cohort study	Adult patients who underwent cardiac surgery in Massachusetts

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jochen D Muehlschlegel, MD, MMSc	Contact	617-732-7330		jmuehlschlegel@bwh.harvard.edu

Overall Officials

Name	Affiliation	Role
Jochen D Muehlschlegel, MD, MMSc	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital	Recruiting	Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 1, 2018	Mar 8, 2018	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke
D003643	Death

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided