Understanding new-onset atrial fibrillation in patients with heart attacks
BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
This study is trying to see how new-onset atrial fibrillation affects heart attack patients and if it can help guide their treatment after they leave the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 774 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 5 sites (Kaifeng, Henan and 4 other locations) |
| Trial ID | NCT04528511 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the prognostic significance of new-onset atrial fibrillation (NOAF) in patients who have experienced an acute myocardial infarction (AMI). It will establish a multicenter, prospective registry involving patients from nine tertiary medical centers in China. The study will collect comprehensive data on patient demographics, cardiovascular risk factors, and NOAF characteristics, including its burden and patterns. Patients will be monitored for at least two years post-discharge to assess cardiovascular outcomes and the potential role of NOAF burden in guiding anticoagulation therapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have experienced an acute myocardial infarction and developed new-onset atrial fibrillation during hospitalization.
Not a fit: Patients with a history of pre-existing atrial fibrillation or those undergoing emergency coronary artery bypass surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve risk stratification and treatment strategies for patients with new-onset atrial fibrillation following a heart attack.
How similar studies have performed: Previous studies have indicated a poor prognosis associated with a greater burden of NOAF in similar patient populations, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kaifeng, Henan and 4 other locations
- Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
- Luoyang Central Hospital — Luoyang, Henan, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Seventh People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yidong Wei, M.D., Ph.D. — Department of Cardiology, Shanghai Tenth People's Hospital
- Study coordinator: Jiachen Luo, M.D., Ph.D.
- Email: messichen@tongji.edu.cn
- Phone: +86-188-0179-0469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.