Acute Myocardial InfarctionSUBDIMA25NCT07492537
SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
A study testing Psychological, Cognitive, and Patient-Reported Outcome Assessments in people with Acute Myocardial Infarction and Subclinical Depression, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Subclinical Depression
- What is being tested?
- Psychological, Cognitive, and Patient-Reported Outcome Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
Roma, Italia, 00168
Fabio Infusino, +390630155701
Fabio Infusino
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychological, Cognitive, and Patient-Reported Outcome Assessments
- Keywords
- Depression, Mental Health, Cardiovascular Outcomes, Quality of Life, Biomarkers, Autonomic Dysfunction, Cognitive Function, Acute Myocardial Infarction, Subclinical Depression, PHQ-9
- Medical subject headings
- Depression, Psychological Well-Being, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological, Cognitive, and Patient-Reported Outcome AssessmentsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Psychological, Cognitive, and Patient-Reported Outcome Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (hospital admission)
Secondary outcomes (8)
C-reactive protein (CRP) levels
Differences in C-reactive protein (CRP) levels between patients with and without subclinical depression.
Measured: 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.
Measured: Baseline, 3 months, and 12 months
NT-proBNP levels
Differences in NT-proBNP levels between patients with and without subclinical depression.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 3 months, and 12 months
Treatment Adherence
Differences in treatment adherence evaluated using the Medication Adherence Report Scale (MARS-5) total score.
Measured: 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.
Measured: Baseline, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start14 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Infusino, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSFederica Mammarella, MD, PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492537
- Sponsor's protocol ID
- 7896
- Acronym
- SUBDIMA25
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUBDIMA Study: Subclinical Depression in Myocardial Infarction -Prevalence, Predictors and Prognostic Impact.
- ClinicalTrials.gov ID
- NCT07492537
- Acronym / sponsor ID
- SUBDIMA25 / 7896
- Keywords
- Depression, Mental Health, Cardiovascular Outcomes, Quality of Life, Biomarkers, Autonomic Dysfunction, Cognitive Function, Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| AMI + Subclinical Depression group | Other | Other: Psychological, Cognitive, and Patient-Reported Outcome AssessmentsPatients 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). |
| AMI NO Subclinical Depression Group | Other | Other: Psychological, Cognitive, and Patient-Reported Outcome AssessmentsPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological, Cognitive, and Patient-Reported Outcome AssessmentsStructured 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 + Subclinical Depression group, AMI NO Subclinical Depression Group |
Primary outcome
Prevalence of Subclinical Depression in Patients with First Acute Myocardial Infarction
Time frame: Baseline (hospital admission)
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.
8 secondary outcomes
C-reactive protein (CRP) levels
Time frame: Baseline, 3 months, and 12 months
Lipid profile
Time frame: Baseline, 3 months, and 12 months
NT-proBNP levels
Time frame: Baseline, 3 months, and 12 months
Cardiac function (LVEF and GLS)
Time frame: Baseline, 3 months, and 12 months
Recurrent Cardiovascular Events
Time frame: Up to 12 months
Quality of Life assessed with EQ-5D-5L and VAS
Time frame: Baseline, 3 months, and 12 months
Treatment Adherence
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Complete blood count (CBC) parameters
Time frame: Baseline, 3 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Infusino principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Federica Mammarella, MD, PhD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological, Cognitive, and Patient-Reported Outcome Assessments in people with Acute Myocardial Infarction and Subclinical Depression, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Infusino, MD, PhD (+390630154187, fabio.infusino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Subclinical Depression in Patients with First Acute Myocardial Infarction (time frame: Baseline (hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.