continuous electronic monitor
DeviceAll patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
NCT Number: NCT04528511
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Kaifeng Central Hospital, Kaifeng, Henan, China
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
Time frame: up to 1 year
Death from any cause
Time frame: up to 1 year
All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths
Time frame: up to 1 year
Heart failure hospitalization is defined as a minimum of an overnight hospital stay of a participant who presented with symptoms and signs of HF or received intravenous diuretics
Time frame: up to 1 year
Recurrent myocardial infarction is defined as the myocardial infarction episode that occurs after 28 days following the index AMI hospitalization.
Time frame: up to 1 year
Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting>24h.
Time frame: up to 1 year
Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5
Contact information is provided by the study sponsor or research team.
Shanghai 10th People's Hospital
Other
BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
Acronym: BENEFIT-AMI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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