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RECRUITING
NCT07492537
NA

SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10-14

Completion Date

2027-10

Last Updated

2026-03-25

Healthy Volunteers

No

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).

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Roma, Italia, Italy