Clinical trial NCT04528511: BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction
Official title: BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation New Onset
Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
New-Onset Atrial Fibrillation
Burden
Prospective
Cardiovascular Outcomes
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Tong Ren Hospital
name: Kaifeng Central Hospital
name: Shanghai 7th People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2020-08-27
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.

Brief summary: To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.

Detailed description: Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old);
* Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
* Patients must have received in-hospital CEM for at least 5 days;
* Patients must give informed consent.

Exclusion Criteria:

* Patients with a medical history of pre-existing AF;
* Patients with a medical history of rheumatic valvular disease;
* Patients with a medical history of sick sinus syndrome;
* Patients undergoing emergent coronary artery bypass surgery;
* Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
* Patients who refuse to receive CEM during hospitalization and the data of heart rhythm cannot be retrieved;
* Patients who refuse to receive percutaneous coronary intervention (PCI) or have contraindications for PCI;
* Patients who have died during the index hospitalization.

Primary outcomes:
measure: All-cause death
timeFrame: up to 1 year
Secondary outcomes:
measure: Cardiovascular death
timeFrame: up to 1 year
measure: Heart failure hospitalization
timeFrame: up to 1 year
measure: Recurrent myocardial infarction
timeFrame: up to 1 year
measure: Ischemic stroke
timeFrame: up to 1 year
measure: Major bleeding
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kai Feng
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: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Seventh People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tong Ren Hospital
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital
name: Yidong Wei, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: