New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

NCT ID: NCT03533543

Last Updated: 2024-07-16

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

COMPLETED

Total Enrollment

2399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-20

Study Completion Date

2019-09-13

Brief Summary

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To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (MI). To explore the prognostic influences of NOAF on MI patients' clinical outcomes. To further investigate the impact of NOAF associated characteristics on patients' clinical outcomes eithier during hospitalization or follow-up period.

Detailed Description

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In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital between February 2014 and March 2018.

All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, acute and dischage medications, and clinical outcomes will be collected. All patients admitt to our CCU department will receive CEM immediately after admission and continue until discharge. Heart thythm status and those characteristics assoicated with NOAF will be reviewed by several independent physicians and recorded in a centralized electronic database.

Several post-MI NOAF assoicated characteristics and definitions are displayed as follows:

1. Total CEM duration is defined as the period during which the monitor was started after admission and turned off before discharge.
2. AF maintained duration is defined as the period during which an AF episode presented and terminated.
3. Total AF duration is calculated by summing all AF episodes' maintained durations descripted above.
4. AF burden was calculated by dividing the total AF duration by the total CEM duration.
5. NOAF pattern included paroxysmal NOAF, persistent NOAF, transient NOAF, and persisting NOAF, definitions are demonstrated as follows:

1\) Paroxysmal NOAF is defined as more than 1 episodes of AF occur during hospitalization irrespective of the discharge rhythm status or only 1 episode of AF is observed during hospitalization and maintain sinus rhythm at discharge.

2\) Persistent NOAF is defined as only 1 episode of AF is observed during hospitalization and maintain AF at discharge.

3\) Transient NOAF is recorded if AF episodes only occur during hospitalization with emergency department ECG, on-admission ECG and discharge ECG maintaining sinus rhythm, irrespective of the frequencies of AF.

4\) Persisting NOAF is recorded if AF episodes occur during hospitalization with a discharge ECG still maintaining AF rhythm, irrespective of the frequencies of AF.

6\. Frequencies of NOAF

7\. Symptomatic and silent NOAF

1. Symptomatic AF is defined as AFresulting in clinical symptoms or the need for urgent cardioversion.
2. Silent AF is defined as any asymptomatic episodes of AF lasting for over 30 seconds at CEM.

Conditions

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Atrial Fibrillation Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

CEM

Intervention Type DEVICE

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.

Non new-onset atrial fibrillation

Patients with MI who are free from a medical history of AF will be recognized as Non-NOAF if they persist with sinus rhythm (based on CEM) during hospitalization.

CEM

Intervention Type DEVICE

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.

Interventions

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CEM

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalized for acute MI between February 2014 and March 2018 in the CCU department of Shanghai Tenth People's Hospital;
* Adult patients (\>18 years old).

Exclusion Criteria

* Patients with a medical history of pre-existing AF;
* Patietns with a medical histroy of Rheumatic valvular disease;
* Patietns with a medical histroy of sick sinus syndrome;
* Patients undergoing emergent coronary artery bypass surgery;
* Patients' medical records with serious deficiencies and critical information (e.g. demographic data, laboratory testings, etc.) cannot be retrieved;
* Patients who refused to receive electronic monitoring during hospitalization and the data of cardiac rhythm cannot be obtained;
* Premature discharge due to nonmedical reasons such as nonpayment, failure to comply with program rules, conflicting with treatment staff, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Locations

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Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Luo J, Xu S, Li H, Gong M, Li Z, Liu B, Qin X, Shi B, Wei Y. Long-term impact of the burden of new-onset atrial fibrillation in patients with acute myocardial infarction: results from the NOAFCAMI-SH registry. Europace. 2021 Feb 5;23(2):196-204. doi: 10.1093/europace/euaa234.

Reference Type RESULT
PMID: 32929491 (View on PubMed)

Luo J, Xu S, Li H, Li Z, Liu B, Qin X, Gong M, Shi B, Wei Y. Long-term impact of new-onset atrial fibrillation complicating acute myocardial infarction on heart failure. ESC Heart Fail. 2020 Oct;7(5):2762-2772. doi: 10.1002/ehf2.12872. Epub 2020 Jun 23.

Reference Type RESULT
PMID: 32578394 (View on PubMed)

Luo J, Liu B, Li H, Xu S, Gong M, Li Z, Qin X, Shi B, Hao C, Zhang J, Wei Y. Prognostic Impact of the Symptom of New-Onset Atrial Fibrillation in Acute Myocardial Infarction: Insights From the NOAFCAMI-SH Registry. Front Cardiovasc Med. 2021 Sep 22;8:677695. doi: 10.3389/fcvm.2021.677695. eCollection 2021.

Reference Type RESULT
PMID: 34631808 (View on PubMed)

Hao C, Luo J, Liu B, Xu W, Li Z, Gong M, Qin X, Shi B, Wei Y. Prognostic Significance of New-Onset Atrial Fibrillation in Heart Failure with Preserved, Mid-Range, and Reduced Ejection Fraction Following Acute Myocardial Infarction: Data from the NOAFCAMI-SH Registry. Clin Interv Aging. 2022 Apr 13;17:479-493. doi: 10.2147/CIA.S358349. eCollection 2022.

Reference Type RESULT
PMID: 35444413 (View on PubMed)

Luo J, Xu S, Li H, Li Z, Gong M, Qin X, Zhang X, Hao C, Liu X, Zhang W, Xu W, Liu B, Wei Y. Prognostic impact of stress hyperglycemia ratio in acute myocardial infarction patients with and without diabetes mellitus. Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2356-2366. doi: 10.1016/j.numecd.2022.07.004. Epub 2022 Jul 16.

Reference Type RESULT
PMID: 35965248 (View on PubMed)

Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Zhang Y, Fang Y, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of the 4S-AF scheme to characterize new-onset atrial fibrillation after myocardial infarction. Eur J Intern Med. 2023 Jul;113:38-44. doi: 10.1016/j.ejim.2023.04.003. Epub 2023 Apr 8.

Reference Type RESULT
PMID: 37037721 (View on PubMed)

Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Association of stress hyperglycemia ratio with in-hospital new-onset atrial fibrillation and long-term outcomes in patients with acute myocardial infarction. Diabetes Metab Res Rev. 2024 Feb;40(2):e3726. doi: 10.1002/dmrr.3726. Epub 2023 Sep 15.

Reference Type RESULT
PMID: 37712510 (View on PubMed)

Luo J, Qin X, Zhang X, Zhang Y, Yuan F, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of systemic immune-inflammation index in myocardial infarction patients with and without diabetes: insights from the NOAFCAMI-SH registry. Cardiovasc Diabetol. 2024 Jan 22;23(1):41. doi: 10.1186/s12933-024-02129-x.

Reference Type RESULT
PMID: 38254086 (View on PubMed)

Luo J, Qin X, Zhang X, Zhang Y, Fang Y, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic impact of new-onset atrial fibrillation in myocardial infarction with and without improved ejection fraction. ESC Heart Fail. 2024 Dec;11(6):3713-3722. doi: 10.1002/ehf2.14956. Epub 2024 Jul 10.

Reference Type RESULT
PMID: 38984376 (View on PubMed)

Other Identifiers

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NOAFCAMI-SH

Identifier Type: -

Identifier Source: org_study_id

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