NCT05511649

Brief Summary

To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

August 20, 2022

Last Update Submit

March 16, 2026

Conditions

Keywords

myocardial infarctionnew-onset atrial fibrillationatrial fibrillation burdenmortality

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Death from any cause

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

Secondary Outcomes (5)

  • Cardiovascular death

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

  • Recurrent myocardial infarction

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

  • Heart failure hospitalization

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

  • Ischemic stroke

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

  • Major bleeding

    From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

Study Arms (2)

Post-MI NOAF with low AF burden

Patients with post-MI NOAF who had a AF burden\<10.87%. The cut-off value of AF burden of 10.87% was identified based on our previous work.

Device: continuous electronic monitor

Post-MI NOAF with high AF burden

Patients with post-MI NOAF who had a AF burden≥10.87%.

Device: continuous electronic monitor

Interventions

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University will receive 24-hour continuous cardiac monitoring until discharge.

Also known as: Philips IntelliVue MP40, Netherlands
Post-MI NOAF with high AF burdenPost-MI NOAF with low AF burden

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with post-MI NOAF

You may qualify if:

  • Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
  • Patients who developed a first documented AF (NOAF) during the index AMI hospitalization;
  • Adult patients (\>18 years old).

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' medical records with serious deficiencies and CEM data cannot be retrieved;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KaiFeng Central Hospital

Kaifeng, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (2)

  • Luo J, Qin X, Yuan Y, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Zhang X, Fang Y, Shi W, Qin L, Liu B, Wei Y; NOAFCAMI-China Registry Investigators. Association of Atrial Fibrillation Burden With Cardiovascular Outcomes in New-Onset Atrial Fibrillation Complicating Myocardial Infarction. J Am Heart Assoc. 2025 May 20;14(10):e039547. doi: 10.1161/JAHA.124.039547. Epub 2025 Apr 16.

  • Luo J, Qin X, Fang Y, Zhang X, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Shi W, Qin L, Liu B, Wei Y. Development and external validation of a prognostic model for new-onset atrial fibrillation complicating acute myocardial infarction: insights from the NOAFCAMI-China registry. Eur Heart J Acute Cardiovasc Care. 2026 Mar 10;15(1):32-41. doi: 10.1093/ehjacc/zuaf122.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yidong Wei, M.D., Ph.D.

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 23, 2022

Study Start

March 1, 2023

Primary Completion

July 27, 2023

Study Completion

September 23, 2023

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations