NCT07416617

Brief Summary

The present study aimed to evaluate the impact of acute insomnia on long-term clinical outcomes in patients underwent PCI or CABG for AMI using the Korean National Health Insurance Service (NHIS) database, and to identify the factors through which insomnia contributes to prognostic determination in this patient population.

Trial Health

63
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Trial Health Score

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

Enrollment
235,342

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress61%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

February 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

acute myocardial infarctioninsomnia

Outcome Measures

Primary Outcomes (1)

  • Rates of MACCE

    a composite of death, spontaneous MI, repeat revascularization, and ischemic stroke

    up to 10 years

Secondary Outcomes (4)

  • Rates of Death

    up to 10 years

  • Rates of Revascularization

    up to 10 years

  • Rates of Spontaneous MI

    up to 10 years

  • Rates of Ischemic stroke

    up to 10 years

Study Arms (2)

No insomina

patient did not have insomia

Insomnia

patient have insomnia

Drug: Insomnia medicationOther: No insomnia medication

Interventions

Diagnosed as insomnia and use of anti-insomnia medication

Insomnia

Diagnosed as insomnia and did not use of anti-insomnia medication

Insomnia

Eligibility Criteria

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

dults aged ≥18 years who were hospitalized between January 1, 2009, and December 31, 2023, with a primary diagnosis of AMI, defined using ICD-10 codes I21-I23 along with procedure codes for revascularization (either PCI or CABG), were included (N = 318,356). Among the participants, we excluded patients with mental disorder prior to incident MI (N =79,133), and patients who die at the diagnosis of AMI (N = 3,881).

You may qualify if:

  • Diagnosis of acute myocardial infarction
  • Undergoing percutaneous coronary intervention or coronary artery bypass surgery

You may not qualify if:

  • Pre-existing phychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Ki Hong Choi, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations