SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
Recruiting · NCT07492537 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is an exploratory, prospective, non-profit study (SUBDIMA) designed to investigate the prevalence and potential prognostic significance of subclinical depression in patients admitted with a first acute myocardial infarction (AMI). Subclinical depression refers to the presence of mild depressive symptoms (PHQ-9 score 5-9) that do not meet DSM-5 TR criteria for major depressive disorder but may still be clinically relevant. The primary aim is to estimate the prevalence of subclinical depression in this setting. Secondary, exploratory objectives include evaluating associations with inflammatory and metabolic biomarkers, autonomic dysfunction, cardiac function, cognitive performance, quality of life, treatment adherence, and the risk of recurrent cardiovascular events over 12 months. The study is expected to generate new descriptive data that may inform future confirmatory trials and support early, personalized approaches to integrated cardiac and mental health care.
Who can take part
Inclusion criteria
- Age ≥18 years
- Hospital admission for first acute myocardial infarction (STEMI or NSTEMI) within 7 days from the index event
- PHQ-9 administered at screening
- Mini Mental State Examination (MMSE) score ≥26
- Written informed consent obtained
Exclusion criteria
- Previous history of acute myocardial infarction
- Diagnosis of major depression according to DSM-5 TR criteria
- Severe cognitive impairment (MMSE \<26)
- Severe comorbidities with expected survival \<12 months
- Inability to participate in scheduled follow-up assessments
- Refusal or inability to provide informed consent
- Concurrent participation in other interventional clinical studies that could interfere with study outcomes
Where it is running
1 location listed.
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia - Roma, Italia, Italy