New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

Atrial Fibrillation Clinical Trial

— NOAFCAMI-SH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533543
• Other study ID #: NOAFCAMI-SH
• Status: Completed
• Start date: May 20, 2018
• Est. completion date: September 13, 2019

Study information

• Verified date: February 2024
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2399
• Est. completion date: September 13, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Hao C, Luo J, Liu B, Xu W, Li Z, Gong M, Qin X, Shi B, Wei Y. Prognostic Significance of New-Onset Atrial Fibrillation in Heart Failure with Preserved, Mid-Range, and Reduced Ejection Fraction Following Acute Myocardial Infarction: Data from the NOAFCAMI- — View Citation

Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Association of stress hyperglycemia ratio with in-hospital new-onset atrial fibrillation and long-term outcomes in patients with acute myocardial infarcti — View Citation

Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Zhang Y, Fang Y, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of the 4S-AF scheme to characterize new-onset atrial fibrillation after myocardial infarction. Eur J Intern Med. — View Citation

Luo J, Liu B, Li H, Xu S, Gong M, Li Z, Qin X, Shi B, Hao C, Zhang J, Wei Y. Prognostic Impact of the Symptom of New-Onset Atrial Fibrillation in Acute Myocardial Infarction: Insights From the NOAFCAMI-SH Registry. Front Cardiovasc Med. 2021 Sep 22;8:6776 — View Citation

Luo J, Qin X, Zhang X, Zhang Y, Yuan F, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of systemic immune-inflammation index in myocardial infarction patients with and without diabetes: insights from the NOAFCAMI-SH registry. Cardiovasc Diabetol. 2024 Jan 22;23(1):41. doi: 10.1186/s12933-024-02129-x. — View Citation

Luo J, Xu S, Li H, Gong M, Li Z, Liu B, Qin X, Shi B, Wei Y. Long-term impact of the burden of new-onset atrial fibrillation in patients with acute myocardial infarction: results from the NOAFCAMI-SH registry. Europace. 2021 Feb 5;23(2):196-204. doi: 10.1 — View Citation

Luo J, Xu S, Li H, Li Z, Gong M, Qin X, Zhang X, Hao C, Liu X, Zhang W, Xu W, Liu B, Wei Y. Prognostic impact of stress hyperglycemia ratio in acute myocardial infarction patients with and without diabetes mellitus. Nutr Metab Cardiovasc Dis. 2022 Oct;32( — View Citation

Luo J, Xu S, Li H, Li Z, Liu B, Qin X, Gong M, Shi B, Wei Y. Long-term impact of new-onset atrial fibrillation complicating acute myocardial infarction on heart failure. ESC Heart Fail. 2020 Oct;7(5):2762-2772. doi: 10.1002/ehf2.12872. Epub 2020 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event (MACE)	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	All-cause death	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
Secondary	Cardiovascular death	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
Secondary	Recurrent myocardial infarction	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
Secondary	Rehospitalization for heart failure	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
Secondary	Stroke	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
Secondary	In-hospital MACE	Cardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days	30 days
Secondary	In-hospital sustained ventricular tachycardia/ventricular fibrillation	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
Secondary	In-hospital cardiogenic shock	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
Secondary	Nonfatal re-infarction at 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
Secondary	Ischemic stroke at 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
Secondary	New congestive heart failure at 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