Skip to content

New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

A Retrospective Cohort Study on the Burden of New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction at Shanghai Tenth People's Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03533543
Acronym
NOAFCAMI-SH
Enrollment
2399
Registered
2018-05-23
Start date
2018-05-20
Completion date
2019-09-13
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Myocardial Infarction

Keywords

Myocardial infarction, New-onset atrial fibrillation, Retrospective, Prognosis

Brief summary

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

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.

Interventions

DEVICECEM

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

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac event (MACE)From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsCardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke

Secondary

MeasureTime frameDescription
Cardiovascular deathFrom the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsDeath from cardiovascular causes
Recurrent myocardial infarctionFrom the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsRehospitalization for myocardial infarction
Rehospitalization for heart failureFrom the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsRehospitalization for heart failure
StrokeFrom the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsStroke is defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting\>24h.
In-hospital MACE30 daysCardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days
All-cause deathFrom the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 yearsDeath from any cause
In-hospital cardiogenic shockFrom the time of admission to coronary care unit until dischargeCardiogenic shock is defined as systolic blood pressure \< 90 mmHg not responsive to fluid resuscitation where IV intropes are required.
Nonfatal re-infarction at 30 days30 daysRe-infarction is defined as recurrent ischemic symptoms\> 20 min with new ST elevation\> 0.1mV in≥ 2 contiguous leads and was verified by an urgent angiography.
Ischemic stroke at 30 days30 daysIschemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting over 24 hours, which is validated based on a computerized tomography (CT) or magnetic resonance imaging (MRI) examination.
New congestive heart failure at 30 days30 daysNew congestive heart failure is defined as the first episode of cardiac decompensation requiring intravenous diuretics when patients suffer chest distress, polypnea or dyspnea.
In-hospital sustained ventricular tachycardia/ventricular fibrillationFrom the time of admission to coronary care unit until dischargeSustianed ventricular tachycardia is defined as ventricular arrhythemia lasting for over 30s where emergent cardioversion is required. Ventricular fibrillation is defined as the heart quivers instead of pumping due to disorganized electrical activity in the ventricles.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026