RecruitingNot ApplicableNCT07492537

SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

100 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

OTHERPsychological, 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

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NCT07492537


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