SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

Recruiting now · Not applicable

Conditions studied: Acute Myocardial Infarction, Subclinical Depression

In brief

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.

Key facts

Study ID

NCT07492537

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

100

Starts

2025-10-14

Expected to finish

2027-10-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia — Roma, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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