An interventional study of Psychological, Cognitive, and Patient-Reported Outcome Assessments in Acute Myocardial Infarction and Subclinical Depression, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Other
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.
Depression is a recognized risk factor for adverse outcomes in patients with acute coronary syndromes. While most studies have focused on major depressive disorder, subclinical depression (defined as PHQ-9 scores between 5 and 9 in the absence of DSM-5 TR criteria for major depression) remains poorly characterized. Its prevalence in patients with a first acute myocardial infarction (AMI) is largely unknown, as are its potential associations with clinical, biological, and psychosocial outcomes.
The SUBDIMA study is a prospective, exploratory, single-center, non-profit clinical investigation conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS. Consecutively admitted patients with a first AMI will undergo systematic screening with the PHQ-9 and a structured clinical assessment to exclude major depression. Based on these evaluations, patients will be classified into two groups: with or without subclinical depression. All participants will be followed for 12 months, with visits at baseline, 3 months, and 12 months, and intermediate phone contacts at 6 and 9 months.
The primary aim of the study is descriptive: to estimate the prevalence of subclinical depression in this population. Secondary, exploratory aims are to examine potential associations between subclinical depression and:
Given its exploratory design, the study is not powered to test confirmatory hypotheses. Instead, it is expected to provide novel descriptive data that will inform the design of future confirmatory trials and contribute to the integration of psychosocial screening in cardiology care pathways.
Exclusion Criteria:
Patients with 1st AMI and PHQ-9 score between 5 and 9 and no DSM-5 TR criteria for major depression. These participants undergo all study assessments at baseline and follow-up (3, 6, 9, and 12 months).
Other: Psychological, Cognitive, and Patient-Reported Outcome Assessments
Patients with 1st AMI and PHQ-9 score \<5 and no DSM-5 TR criteria for major depression. These participants undergo the same study assessments as the Subclinical Depression Group (baseline and follow-up at 3, 6, 9, and 12 months).
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).
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)
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 months
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 months
NT-proBNP levels
Differences in NT-proBNP levels between patients with and without subclinical depression.
Time frame: Baseline, 3 months, and 12 months
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 months
Recurrent Cardiovascular Events
Incidence of recurrent ischemic events (AMI, stroke, peripheral ischemia), hospitalization for cardiovascular causes, and cardiovascular mortality.
Time frame: Up to 12 months
Quality of Life assessed with EQ-5D-5L and VAS
Quality of life assessed using the EuroQol-5D-5L (EQ-5D-5L), including utility index and visual analogue scale (VAS).
Time frame: Baseline, 3 months, and 12 months
Treatment Adherence
Differences in treatment adherence evaluated using the Medication Adherence Report Scale (MARS-5) total score.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Complete blood count (CBC) parameters
Differences in complete blood count parameters, including hemoglobin, white blood cell count, and platelet count, between patients with and without subclinical depression. Each parameter will be analyzed separately.
Time frame: Baseline, 3 months, and 12 months
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 months
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 months
Dietary Pattern (Medi-Lite Score)
Dietary habits assessed with the Medi-Lite Score.
Time frame: Baseline, 3 months, and 12 months
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 months
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS