Recruiting

SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

ClinicalTrials.gov IDNCT07492537

PhaseNA

Enrollment100

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Age18 Years

SexALL

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Conditions studied

Acute Myocardial Infarction, Subclinical Depression

About this study

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.

Interventions

Other: Psychological, Cognitive, and Patient-Reported Outcome Assessments — Structured evaluation including PHQ-9, BDI-II, HAM-A, cognitive tests (CVLT-2, Matrici Attentive, Rey-Osterrieth), and validated questionnaires (EQ-5D-5L, PSQI, IPAQ, Medi-Lite, MARS-5) administered at baseline and during follow-up (3, 6, 9, and 12 months).

Primary outcomes

Prevalence of Subclinical Depression in Patients with First Acute Myocardial Infarction (Baseline (hospital admission))

Eligibility information

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

Study locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia, Roma, Italia 00168 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.