BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Continuous Electronic Monitor
DeviceAll patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
Treatment groups
774 Participants
are divided into 2 treatment groupsGroup A: Low burden of new-onset atrial fibrillation1 intervention
Group B: High burden of new-onset atrial fibrillation1 intervention
Trial outcomes
Primary outcomes
1
All-cause death
Death from any cause
Time frame
up to 1 yearSecondary outcomes
1
Cardiovascular death
All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths
Time frame
up to 1 year2
Heart failure hospitalization
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 year3
Recurrent myocardial infarction
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 year4
Ischemic stroke
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai 10th People's Hospital
Lead sponsor
Shanghai Tong Ren Hospital
Collaborator
Kaifeng Central Hospital
Collaborator
Shanghai 7th People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Luoyang Central Hospital
Collaborator
Source ClinicalTrials.gov