NCT04528511

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
774

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Oct 2020Jun 2028

First Submitted

Initial submission to the registry

August 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

7.3 years

First QC Date

August 23, 2020

Last Update Submit

March 16, 2026

Conditions

Atrial Fibrillation New OnsetAcute Myocardial Infarction

Keywords

Acute Myocardial InfarctionNew-Onset Atrial FibrillationBurdenProspectiveCardiovascular Outcomes

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Death from any cause

    up to 1 year

Secondary Outcomes (5)

  • Cardiovascular death

    up to 1 year

  • Heart failure hospitalization

    up to 1 year

  • Recurrent myocardial infarction

    up to 1 year

  • Ischemic stroke

    up to 1 year

  • Major bleeding

    up to 1 year

Study Arms (2)

Low burden of new-onset atrial fibrillation

Patients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. Among this subset of patients, those who have a NOAF burden value\<10.87% (previously established) will be divided into the low burden group.

Device: Continuous Electronic Monitor

High burden of new-onset atrial fibrillation

For patients with NOAF complicating AMI, those who have a NOAF burden value≥10.87% (previously established) will be divided into the high burden group.

Device: Continuous Electronic Monitor

Interventions

Continuous Electronic MonitorDEVICE

All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

High burden of new-onset atrial fibrillationLow burden of new-onset atrial fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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, 200072, China

RECRUITING

Shanghai Seventh People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

  • Yidong Wei, M.D., Ph.D.

    Department of Cardiology, Shanghai Tenth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiachen Luo, M.D., Ph.D.

CONTACT

+86-188-0179-0469messichen@tongji.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 27, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

CN(5)