Clinical trial NCT05511649: New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China
Official title: The Prognostic Impacts and Clinical Utility of the Characteristics of New-onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Onset Atrial Fibrillation
Acute Myocardial Infarction
Keywords: myocardial infarction
new-onset atrial fibrillation
atrial fibrillation burden
mortality
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Kaifeng Central Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2022-08-23
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with post-MI NOAF

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.

Eligibility criteria: 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;

Primary outcomes:
measure: All-cause death
timeFrame: 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 outcomes:
measure: Cardiovascular death
timeFrame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
measure: Recurrent myocardial infarction
timeFrame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
measure: Heart failure hospitalization
timeFrame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
measure: Ischemic stroke
timeFrame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
measure: Major bleeding
timeFrame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: KaiFeng Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yidong Wei, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo J, Qin X, Yuan Y, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Zhang X, Fang Y, Shi W, Qin L, Liu B, Wei Y; NOAFCAMI-China Registry Investigators. Association of Atrial Fibrillation Burden With Cardiovascular Outcomes in New-Onset Atrial Fibrillation Complicating Myocardial Infarction. J Am Heart Assoc. 2025 May 20;14(10):e039547. doi: 10.1161/JAHA.124.039547. Epub 2025 Apr 16.