SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

NCT07492537 | Recruiting

• 1 other identifier: 7896
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction; Subclinical Depression

Keywords

Depression; Mental Health; Cardiovascular Outcomes; Quality of Life; Biomarkers; Autonomic Dysfunction; Cognitive Function; Acute Myocardial Infarction; Subclinical Depression; PHQ-9

Outcome Measures

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.

  Baseline (hospital admission)

Secondary Outcomes (8)

• C-reactive protein (CRP) levels

  Baseline, 3 months, and 12 months

• Lipid profile

  Baseline, 3 months, and 12 months

• NT-proBNP levels

  Baseline, 3 months, and 12 months

• Cardiac function (LVEF and GLS)

  Baseline, 3 months, and 12 months

• Recurrent Cardiovascular Events

  Up to 12 months

Other Outcomes (4)

• Sleep Quality assessed with PSQI

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Physical Activity assessed with IPAQ

  Baseline, 3 months, 6 months, 9 months, and 12 months

• Dietary Pattern (Medi-Lite Score)

  Baseline, 3 months, and 12 months

Study Arms (2)

AMI + Subclinical Depression group

OTHER

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

AMI NO Subclinical Depression Group

OTHER

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

Interventions

Psychological, Cognitive, and Patient-Reported Outcome Assessments OTHER

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).

AMI + Subclinical Depression group; AMI NO Subclinical Depression Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Roma, Italia, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Depression; Psychological Well-Being; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Fabio Infusino

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Infusino, MD, PhD

CONTACT

+390630154187; fabio.infusino@policlinicogemelli.it

Federica Mammarella, MD, PhD

CONTACT

+390630154187; federica.mammarella@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied. Both investigators and participants will be aware of group classification (open label).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, exploratory study with two parallel groups. Patients admitted with a first acute myocardial infarction are consecutively screened and classified into two groups: with or without subclinical depression, according to PHQ-9 scores and DSM-5 TR criteria. All patients undergo the same assessments at baseline and during follow-up (3, 6, 9, and 12 months).

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: March 25, 2026
• Study Start: October 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-12

Locations

IT (1)