NOAFCAMI-SH: New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03533543

Collaborator

(none)

2,399

Enrollment

Location

15.8

Actual Duration (Months)

151.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Myocardial Infarction	Device: CEM

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:

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

NOAF, definitions are demonstrated as follows:

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.
Persistent NOAF is defined as only 1 episode of AF is observed during hospitalization and maintain AF at discharge.
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.
Persisting NOAF is recorded if AF episodes occur during hospitalization with a discharge ECG still maintaining AF rhythm, irrespective of the frequencies of AF.

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

Study Design

Study Type:

Observational

Actual Enrollment :

2399 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 20, 2018

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Sep 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: CEM 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.	Device: CEM All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.

Arm

Intervention/Treatment

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.

Device: CEM

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.

Device: CEM

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

Outcome Measures

Primary Outcome Measures

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 years]
Cardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke

Secondary Outcome Measures

All-cause death [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 years]
Death from any cause
Cardiovascular death [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 years]
Death from cardiovascular causes
Recurrent myocardial infarction [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 years]
Rehospitalization for myocardial infarction
Rehospitalization for heart failure [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 years]
Rehospitalization for heart failure
Stroke [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 years]
Stroke 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 MACE [30 days]
Cardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days
In-hospital sustained ventricular tachycardia/ventricular fibrillation [From the time of admission to coronary care unit until discharge]
Sustianed 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.
In-hospital cardiogenic shock [From the time of admission to coronary care unit until discharge]
Cardiogenic shock is defined as systolic blood pressure < 90 mmHg not responsive to fluid resuscitation where IV intropes are required.
Nonfatal re-infarction at 30 days [30 days]
Re-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 days [30 days]
Ischemic 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 days [30 days]
New congestive heart failure is defined as the first episode of cardiac decompensation requiring intravenous diuretics when patients suffer chest distress, polypnea or dyspnea.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.