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

February 2, 2024 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2399

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Department of Cardiology, Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute MI without a medical history of AF.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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.
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 MACE
Time Frame: 30 days
Cardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days
30 days
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.
From the time of admission to coronary care unit until discharge
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.
From the time of admission to coronary care unit until discharge
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.
30 days
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.
30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Yidong Wei, MD, PhD, Department of Cardiology, Shanghai Tenth People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

September 13, 2019

Study Registration Dates

First Submitted

April 28, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOAFCAMI-SH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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