Impact of New-onset Insomnia After Coronary Revasculariza... | NCT07416617

Studies
Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction

NCT07416617

Sponsor

Samsung Medical Center

Status

Not yet recruiting

Last Update Posted

Feb 18, 2026Actual

Enrollment

235,342Estimated

Phase

Not provided

Conditions

Acute Myocardial Infarction
Insomina

Interventions

Insomnia medication
No insomnia medication

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2026Estimated

Primary Completion Date

May 31, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

235,342Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No insomina		patient did not have insomia
Insomnia		patient have insomnia	Drug: Insomnia medication Other: No insomnia medication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insomnia medication	Drug	Diagnosed as insomnia and use of anti-insomnia medication	Insomnia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates of MACCE	a composite of death, spontaneous MI, repeat revascularization, and ischemic stroke	up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Rates of Death	All-cause death	up to 10 years
Rates of Revascularization	repeat revascularization	up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pre-existing phychiatric disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ki Hong Choi, MD, PhD	Contact	+82234100897		cardiokh@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided