Impact of New-onset Insomnia After Coronary Revascularization for Patients With Acute Myocardial Infarction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of acute myocardial infarction
Undergoing percutaneous coronary intervention or coronary artery bypass surgery
Disqualifiers
Pre-existing phychiatric disorders
Trial 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).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Insomnia medication
DrugDiagnosed as insomnia and use of anti-insomnia medication
No insomnia medication
Other interventionDiagnosed as insomnia and did not use of anti-insomnia medication
Treatment groups
235,342 Participants
are divided into 2 treatment groupsGroup A: No insomina0 interventions
Group B: Insomnia2 interventions
Trial outcomes
Primary outcomes
1
Rates of MACCE
a composite of death, spontaneous MI, repeat revascularization, and ischemic stroke
Time frame
up to 10 yearsSecondary outcomes
1
Rates of Death
All-cause death
Time frame
up to 10 years2
Rates of Revascularization
repeat revascularization
Time frame
up to 10 years3
Rates of Spontaneous MI
MI
Time frame
up to 10 years4
Rates of Ischemic stroke
Stroke
Time frame
up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov
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