Actively Recruiting
SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-03-25
100
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Hospital admission for first acute myocardial infarction (STEMI or NSTEMI) within 7 days from the event
- PHQ-9 questionnaire completed at screening
- Mini Mental State Examination (MMSE) score of 26 or higher
- Written informed consent provided
You will not qualify if you...
- Previous history of acute myocardial infarction
- Diagnosis of major depression according to DSM-5 TR criteria
- Severe cognitive impairment with MMSE score below 26
- Severe comorbid conditions with expected survival less than 12 months
- Unable to participate in scheduled follow-up assessments
- Refusal or inability to give informed consent
- Participation in other interventional clinical studies that might affect results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
Roma, Italia, Italy, 00168
Actively Recruiting
Research Team
F
Fabio Infusino, MD, PhD
CONTACT
F
Federica Mammarella, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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