BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction

NCT ID: NCT04528511

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

774 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-03-31

Brief Summary

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To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.

Detailed Description

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Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.

Conditions

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Atrial Fibrillation New Onset Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low burden of new-onset atrial fibrillation

Patients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. Among this subset of patients, those who have a NOAF burden value\<10.87% (previously established) will be divided into the low burden group.

Continuous Electronic Monitor

Intervention Type DEVICE

All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

High burden of new-onset atrial fibrillation

For patients with NOAF complicating AMI, those who have a NOAF burden value≥10.87% (previously established) will be divided into the high burden group.

Continuous Electronic Monitor

Intervention Type DEVICE

All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Interventions

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Continuous Electronic Monitor

All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18 years old);
* Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
* Patients must have received in-hospital CEM for at least 5 days;
* Patients must give informed consent.

Exclusion Criteria

* Patients with a medical history of pre-existing AF;
* Patients with a medical history of rheumatic valvular disease;
* Patients with a medical history of sick sinus syndrome;
* Patients undergoing emergent coronary artery bypass surgery;
* Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
* Patients who refuse to receive CEM during hospitalization and the data of heart rhythm cannot be retrieved;
* Patients who refuse to receive percutaneous coronary intervention (PCI) or have contraindications for PCI;
* Patients who have died during the index hospitalization.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Tong Ren Hospital

OTHER

Sponsor Role collaborator

Kaifeng Central Hospital

OTHER

Sponsor Role collaborator

Shanghai 7th People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yidong Wei, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Locations

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Kaifeng Central Hospital

Kaifeng, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Seventh People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiachen Luo, M.D., Ph.D.

Role: CONTACT

+86-188-0179-0469

Facility Contacts

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Hongqiang Li, M.D., Ph.D.

Role: primary

Jiachen Luo, M.D., Ph.D.

Role: primary

+86-188-0179-0469

Other Identifiers

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BENEFIT-AMI

Identifier Type: -

Identifier Source: org_study_id

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