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RECRUITINGINTERVENTIONAL

SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

SUBDIMA Study: Subclinical Depression in Myocardial Infarction -Prevalence, Predictors and Prognostic Impact.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form obtained Who Should NOT Join This Trial: - 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 willing to sign a consent form - Concurrent participation in other interventional clinical studies that could interfere with study outcomes Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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).

Locations (1)

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