SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Psychological, Cognitive, and Patient-Reported Outcome Assessments
Other interventionStructured 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: AMI + Subclinical Depression groupOther 1 intervention
Group B: AMI NO Subclinical Depression GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of Subclinical Depression in Patients with First Acute Myocardial Infarction
Proportion of patients with PHQ-9 score between 5 and 9 who do not meet DSM-5 TR criteria for major depression among those admitted with first acute myocardial infarction.
Time frame
Baseline (hospital admission)Secondary outcomes
1
C-reactive protein (CRP) levels
Differences in C-reactive protein (CRP) levels between patients with and without subclinical depression.
Time frame
Baseline, 3 months, and 12 months2
Lipid profile
Differences in lipid profile parameters, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, between patients with and without subclinical depression. Each parameter will be analyzed separately.
Time frame
Baseline, 3 months, and 12 months3
NT-proBNP levels
Differences in NT-proBNP levels between patients with and without subclinical depression.
Time frame
Baseline, 3 months, and 12 months4
Cardiac function (LVEF and GLS)
Cardiac function assessed by left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS). Each parameter will be analyzed separately.
Time frame
Baseline, 3 months, and 12 monthsOther outcomes
1
Sleep Quality assessed with PSQI
Exploratory, descriptive analysis of sleep quality using the Pittsburgh Sleep Quality Index (PSQI).
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months2
Physical Activity assessed with IPAQ
Physical activity assessed with International Physical Activity Questionnaire (IPAQ) score.
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months3
Dietary Pattern (Medi-Lite Score)
Dietary habits assessed with the Medi-Lite Score.
Time frame
Baseline, 3 months, and 12 months4
Cognitive function (composite neuropsychological assessment)
Cognitive performance assessed using California Verbal Learning Test-II (CVLT-II), Attentive Matrices, and Rey-Osterrieth Complex Figure test.
Time frame
Baseline, 3 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov