Subclinical depression in people after a first heart attack (SUBDIMA25)
Official title: SUBDIMA Study: Subclinical Depression in Myocardial Infarction -Prevalence, Predictors and Prognostic Impact.
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07492537 · Data updated 2026-11-12
This project will test how common mild depressive symptoms are in adults hospitalized for a first heart attack and whether those symptoms relate to biomarkers, heart function, and recovery over the next year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Italia) |
| Status | Recruiting |
| Started | October 14, 2025 |
| Main results expected | October 2026 |
| Study ends | October 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07492537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older admitted for a first STEMI or NSTEMI within 7 days who can complete the PHQ-9 and MMSE (score ≥26) and are able to provide informed consent are ideal candidates.
✕Probably not a fit
Patients with prior myocardial infarction, current major depressive disorder, severe cognitive impairment (MMSE <26), limited life expectancy <12 months, inability to attend follow-up, or participation in conflicting interventional trials are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SUBDIMA is a prospective, single-center, exploratory investigation enrolling consecutive adults admitted with a first acute myocardial infarction who are screened with the PHQ-9 and a structured clinical interview to exclude major depressive disorder. Participants will be classified as having subclinical depression (PHQ-9 5–9 without DSM-5 TR major depression) or not, then followed for 12 months with in-person visits at baseline, 3 months, and 12 months and phone contacts at 6 and 9 months. Secondary, exploratory analyses will examine associations between subclinical depressive symptoms and inflammatory and metabolic biomarkers, autonomic function (e.g., heart rate variability), cardiac function measures, cognitive performance, quality of life, treatment adherence, and recurrent cardiovascular events. The study is descriptive and intended to generate data to guide future confirmatory trials and integrated cardiac–mental health approaches.
Why it matters
Potential benefit: If successful, the findings could help identify patients with mild depressive symptoms who might benefit from earlier integrated cardiac and mental health support to improve recovery and reduce the risk of recurrent events.
How similar studies have gone: Prior research has linked major depression after myocardial infarction to worse outcomes, but studies specifically targeting subclinical depressive symptoms in this setting are limited and largely exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
Roma, Italia, Italy Recruiting
Study contacts
- Principal investigator: Fabio Infusino — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Fabio Infusino, MD, PhD
- Email: fabio.infusino@policlinicogemelli.it
- Phone: +390630154187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.