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Completed

NCT Number: NCT03533543

New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEM

Device

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

Primary outcomes

  1. Major adverse cardiac event (MACE)

    Time frame: 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 outcomes

  1. All-cause death

    Time frame: 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

  2. Cardiovascular death

    Time frame: 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

  3. Recurrent myocardial infarction

    Time frame: 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

  4. Rehospitalization for heart failure

    Time frame: 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

  5. Stroke

    Time frame: 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.

  6. In-hospital MACE

    Time frame: 30 days

    Cardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days

  7. In-hospital sustained ventricular tachycardia/ventricular fibrillation

    Time frame: 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.

  8. In-hospital cardiogenic shock

    Time frame: 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.

  9. Nonfatal re-infarction at 30 days

    Time frame: 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.

  10. Ischemic stroke at 30 days

    Time frame: 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.

  11. New congestive heart failure at 30 days

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Acronym: NOAFCAMI-SH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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