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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04528511
Other study ID # BENEFIT-AMI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date March 31, 2025

Study information

Verified date June 2023
Source Shanghai 10th People's Hospital
Contact Jiachen Luo, M.D., Ph.D.
Phone +86-188-0179-0469
Email messichen@tongji.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 774
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
Continuous Electronic Monitor
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Locations

Country Name City State
China Kaifeng Central Hospital Kai Feng Henan
China Department of Cardiology, Shanghai Tenth People's Hospital Shanghai Shanghai
China Shanghai Seventh People's Hospital Shanghai Shanghai
China Shanghai Tong Ren Hospital Shanghai Shanghai
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (5)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital Kaifeng Central Hospital, Shanghai 7th People's Hospital, Shanghai Tong Ren 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 up to 1 year
Secondary Cardiovascular death All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths up to 1 year
Secondary 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 up to 1 year
Secondary Recurrent myocardial infarction Recurrent myocardial infarction is defined as the myocardial infarction episode that occurs after 28 days following the index AMI hospitalization. up to 1 year
Secondary 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. up to 1 year
Secondary Major bleeding Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5 up to 1 year
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