New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

Completed

• Conditions: New Onset Atrial Fibrillation; Acute Myocardial Infarction
• Interventions: Device: continuous electronic monitor

• Registration Number: NCT05511649
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.

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, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University between January 2014 and January 2022. All patients will routinely receive continuous electronic monitoring (CEM) throughout their hospital stay to detect cardiac arrhythmias including the AF events. Of these, patients with AMI without a history of AF who developed a first documented AF episode will be considered for inclusion. The AFb is measured as a percentage (%) by dividing the total AF duration by the total CEM duration.

Study Timeline

• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-20
• Study First Posted: 2022-08-23
• Study Start: 2023-03-01
• Primary Completion: 2023-07-27
• Status Verified: 2023-09
• Study Completion: 2023-09-23
• Last Update Submitted: 2023-09-23
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

Inclusion Criteria

1. Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
2. Patients who developed a first documented AF (NOAF) during the index AMI hospitalization；
3. Adult patients (>18 years old).

Exclusion Criteria

1. Patients with a medical history of pre-existing AF;
2. Patients with a medical history of rheumatic valvular disease;
3. Patients with a medical history of sick sinus syndrome;
4. Patients undergoing emergent coronary artery bypass surgery;
5. Patients' medical records with serious deficiencies and CEM data cannot be retrieved;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-MI NOAF with high AF burden	continuous electronic monitor	Patients with post-MI NOAF who had a AF burden≥10.87%.
Post-MI NOAF with low AF burden	continuous electronic monitor	Patients with post-MI NOAF who had a AF burden\<10.87%. The cut-off value of AF burden of 10.87% was identified based on our previous work.

Primary Outcome Measures

Name	Time	Method
All-cause death	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Recurrent myocardial infarction	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	Rehospitalization for myocardial infarction
Cardiovascular death	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	Death from cardiovascular causes
Ischemic stroke	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	Ischemic stroke was identified as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting\> 24 hours, and was validated according to radiographic imaging test.
Heart failure hospitalization	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	HF hospitalization was based on clinical symptoms such as dyspnea and fatigue, and signs of peripheral or pulmonary edema that required hospitalization for intravenous diuretic treatment
Major bleeding	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years	Bleeding event with a Bleeding Academic Research Consortium (BARC) classification of types 3 or 5.

Trial Locations

Locations (3)

KaiFeng Central Hospital; 🇨🇳 Kaifeng, Henan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China