Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction (MI-INSOMINA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction; Insomina
• Intervention / Treatment: Drug: Insomnia medication; Other: No insomnia medication

• Study Type: Observational
• Enrollment (Estimated): 235342

Contacts and Locations

• Study Contact: Name: Ki Hong Choi, MD, PhD; Phone Number: +82234100897; Email: cardiokh@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Samsung Medical Center
    • Contact: 기홍 최, MD, PhD; Phone Number: 01088751648; Email: cardiokh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pre-existing phychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No insomina; patient did not have insomia
Insomnia; patient have insomnia	Drug: Insomnia medication; Diagnosed as insomnia and use of anti-insomnia medication; Other: No insomnia medication; Diagnosed as insomnia and did not use of anti-insomnia medication

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Death	All-cause death	up to 10 years
Rates of Revascularization	repeat revascularization	up to 10 years
Rates of Spontaneous MI	MI	up to 10 years
Rates of Ischemic stroke	Stroke	up to 10 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; acute myocardial infarction
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: MI_Insomnia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No