Atrial FibrillationMATRICeSNCT03466125
Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery
An observational study of Atrial Fibrillation and Stroke, Acute, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Stroke, Acute, Death
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016
Who may be able to join
- Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jochen D Muehlschlegel, MD, MMSc, 617-525-8156, jmuehlschlegel@bwh.harvard.edu
Jochen D Muehlschlegel, MD, MMSc
About this study
Official title: 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:
- 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.
- Conditions
- Atrial Fibrillation, Stroke, Acute, Death
- Being tested
- Cardiac surgery
- Medical subject headings
- Atrial Fibrillation, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Retrospective cohort study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent atrial fibrillation
Recurrent atrial fibrillation
Measured: Up to six years after surgery
Acute ischemic stroke
Acute ischemic stroke
Measured: Up to six years after surgery
Mortality
Mortality
Measured: Up to six years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jan 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
- Investigators
- Jochen D Muehlschlegel, MD, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466125
- Sponsor's protocol ID
- 2017P002261
- Acronym
- MATRICeS
- Status last verified
- Feb 2023
- First submitted
- 5 Mar 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massachusetts-wide Study of the Incidence of ATrial Fibrillation and Stroke Occurring After Discharge From Cardiac Surgery (MATRICeS)
- ClinicalTrials.gov ID
- NCT03466125
- Acronym / sponsor ID
- MATRICeS / 2017P002261
- Conditions
- Atrial Fibrillation, Stroke, Acute, Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients who underwent cardiac surgery in Massachusetts | – | Procedure: Cardiac surgeryNo interventions. A retrospective cohort study of patients who underwent cardiac surgery in Massachusetts in calendar years 2012 - 2016. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016
Key inclusion criteria (1 listed)
- Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryRetrospective cohort study | Procedure or surgery | Adult patients who underwent cardiac surgery in Massachusetts |
Primary outcome
Recurrent atrial fibrillation
Time frame: Up to six years after surgery
Recurrent atrial fibrillation
Acute ischemic stroke
Time frame: Up to six years after surgery
Acute ischemic stroke
Mortality
Time frame: Up to six years after surgery
Mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen D Muehlschlegel, MD, MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, Acute, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jochen D Muehlschlegel, MD, MMSc (617-732-7330, jmuehlschlegel@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent atrial fibrillation (time frame: Up to six years after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.