Acute Myocardial InfarctionMI-INSOMINANCT07416617
Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction and Insomina, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Insomina
- What is being tested?
- Insomnia medication and No insomnia medication
- How many people
- 235,342 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Feb 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- Diagnosis of acute myocardial infarction
- Undergoing percutaneous coronary intervention or coronary artery bypass surgery
Who cannot join
- Pre-existing phychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, 06351
기홍 최, MD, PhD, 01088751648, cardiokh@gmail.com
About this study
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.
- Conditions
- Acute Myocardial Infarction, Insomina
- Being tested
- Insomnia medication, No insomnia medication
- Keywords
- acute myocardial infarction, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia medicationDrug
Diagnosed as insomnia and use of anti-insomnia medication
No insomnia medicationOther
Diagnosed as insomnia and did not use of anti-insomnia medication
| Study group | Role | What they receive |
|---|---|---|
| No insomina | patient did not have insomia | |
| Insomnia | patient have insomnia Receives: Drug: Insomnia medication; Other: No insomnia medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of MACCE
a composite of death, spontaneous MI, repeat revascularization, and ischemic stroke
Measured: up to 10 years
Secondary outcomes (4)
Rates of Death
All-cause death
Measured: up to 10 years
Rates of Revascularization
repeat revascularization
Measured: up to 10 years
Rates of Spontaneous MI
MI
Measured: up to 10 years
Rates of Ischemic stroke
Stroke
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 235,342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416617
- Sponsor's protocol ID
- MI_Insomnia
- Acronym
- MI-INSOMINA
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07416617
- Acronym / sponsor ID
- MI-INSOMINA / MI_Insomnia
- Conditions
- Acute Myocardial Infarction, Insomina
- Keywords
- acute myocardial infarction, insomnia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 235,342 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No insomina | – | –patient did not have insomia |
| Insomnia | – | Drug: Insomnia medication, Other: No insomnia medicationpatient have insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (2 listed)
- Diagnosis of acute myocardial infarction
- Undergoing percutaneous coronary intervention or coronary artery bypass surgery
Key exclusion criteria (1 listed)
- Pre-existing phychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insomnia medicationDiagnosed as insomnia and use of anti-insomnia medication | Drug | Insomnia |
| No insomnia medicationDiagnosed as insomnia and did not use of anti-insomnia medication | Other | Insomnia |
Primary outcome
Rates of MACCE
Time frame: up to 10 years
a composite of death, spontaneous MI, repeat revascularization, and ischemic stroke
4 secondary outcomes
Rates of Death
Time frame: up to 10 years
Rates of Revascularization
Time frame: up to 10 years
Rates of Spontaneous MI
Time frame: up to 10 years
Rates of Ischemic stroke
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Insomina, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ki Hong Choi, MD, PhD (+82234100897, cardiokh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of MACCE (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.