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Clinical Trials/NCT03533543
NCT03533543
Completed
Not Applicable

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

Shanghai 10th People's Hospital1 site in 1 country2,399 target enrollmentMay 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Shanghai 10th People's Hospital
Enrollment
2399
Locations
1
Primary Endpoint
Major adverse cardiac event (MACE)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2018
End Date
September 13, 2019
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ya-Wei Xu

Chief Physician

Shanghai 10th People's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • Ischemic stroke at 30 days(30 days)
  • 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)
  • 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 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)
  • In-hospital cardiogenic shock(From the time of admission to coronary care unit until discharge)
  • New congestive heart failure at 30 days(30 days)
  • In-hospital MACE(30 days)
  • Nonfatal re-infarction at 30 days(30 days)
  • In-hospital sustained ventricular tachycardia/ventricular fibrillation(From the time of admission to coronary care unit until discharge)

Study Sites (1)

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