New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

Acute Myocardial Infarction Clinical Trial

— NOAFCAMI-China  

Official title:

The Prognostic Impacts and Clinical Utility of the Characteristics of New-onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511649
• Other study ID #: NOAFCAMI-China
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: September 23, 2023

Study information

• Verified date: September 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: September 23, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Atrial Fibrillation
• Infarction
• Myocardial Infarction
• New Onset Atrial Fibrillation

Intervention

Device:
• continuous electronic monitor
All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University will receive 24-hour continuous cardiac monitoring until discharge.

Locations

Country	Name	City	State
China	KaiFeng Central Hospital	Kaifeng	Henan
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Death from any cause	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Secondary	Cardiovascular death	Death from cardiovascular causes	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Secondary	Recurrent myocardial infarction	Rehospitalization for 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
Secondary	Heart failure hospitalization	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	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Secondary	Ischemic stroke	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.	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Secondary	Major bleeding	Bleeding event with a Bleeding Academic Research Consortium (BARC) classification of types 3 or 5.	From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years