SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25) (SUBDIMA25)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction; Subclinical Depression
• Intervention / Treatment: Other: Psychological, Cognitive, and Patient-Reported Outcome Assessments

Detailed Description

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:

• inflammatory and metabolic biomarkers,
• measures of autonomic dysfunction (e.g., heart rate variability),
• cardiac function parameters (e.g., echocardiographic strain indices, NT-proBNP),
• cognitive and anxiety assessments,
• health-related quality of life and lifestyle factors,
• adherence to treatment,
• and the incidence of recurrent cardiovascular events during follow-up.

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Infusino, MD, PhD; Phone Number: +390630154187; Email: fabio.infusino@policlinicogemelli.it
• Study Contact Backup: Name: Federica Mammarella, MD, PhD; Phone Number: +390630154187; Email: federica.mammarella@policlinicogemelli.it

Study Locations

• Italy
  • Italia
    • Roma, Italia, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
      • Contact: Fabio Infusino; Phone Number: +390630155701
      • Principal Investigator: Fabio Infusino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AMI + Subclinical Depression group; 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; 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).
Other: AMI NO Subclinical Depression Group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (hospital admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein (CRP) levels	Differences in C-reactive protein (CRP) levels between patients with and without subclinical depression.	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.	Baseline, 3 months, and 12 months
NT-proBNP levels	Differences in NT-proBNP levels between patients with and without subclinical depression.	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.	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.	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).	Baseline, 3 months, and 12 months
Treatment Adherence	Differences in treatment adherence evaluated using the Medication Adherence Report Scale (MARS-5) total score.	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.	Baseline, 3 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality assessed with PSQI	Exploratory, descriptive analysis of sleep quality using the Pittsburgh Sleep Quality Index (PSQI).	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.	Baseline, 3 months, 6 months, 9 months, and 12 months
Dietary Pattern (Medi-Lite Score)	Dietary habits assessed with the Medi-Lite Score.	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.	Baseline, 3 months, and 12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Fabio Infusino, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 3, 2025
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Depression; Mental Health; Quality of Life; Biomarkers; Cognitive Function; Autonomic Dysfunction; Cardiovascular Outcomes; PHQ-9; Subclinical Depression
• Additional Relevant MeSH Terms: Nervous System Diseases; Behavioral Symptoms; Autonomic Nervous System Diseases; Behavior; Personal Satisfaction; Depression; Primary Dysautonomias; Psychological Well-Being
• Other Study ID Numbers: 7896

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No