Coronary Artery DieaseFAMILYNCT07352111
High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction
A study testing Cardiac CT in people with Coronary Artery Diease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The evidence of high-risk atherosclerosis at cardiac CT (CCT) may support aggressive primary prevention treatment, reducing the risk of future cardiovascular events. Family history of coronary artery disease (CAD) is a risk factor for cardiovascular events but limited data described the prevalence of coronary… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Diease
- What is being tested?
- Cardiac CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2025to 31 Dec 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with postive family history of CAD
Who cannot join
- known cardiovascular diseases
- any symptoms
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
Ospedale Galeazzi-Sant'Ambrogio IRCCS
Milan
Elena Cittera, 0039 02 83502227, direzionescientifica.ogsa@grupposandonato.it
About this study
Official title: High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction; the FAMILY Study
The evidence of high-risk atherosclerosis at cardiac CT (CCT) may support aggressive primary prevention treatment, reducing the risk of future cardiovascular events. Family history of coronary artery disease (CAD) is a risk factor for cardiovascular events but limited data described the prevalence of coronary atherosclerosis in these patients.
Aims of the FAMILY project are to explore the prevalence of high-risk coronary atherosclerosis among patients with family history of CAD, to explore whether CCT in this setting may to reclassify patients' vs standard of care and to explore correlations between genetic background and high risk and potentially unstable coronary atherosclerosis.
A consecutive cohort of asymptomatic of patients with family history of CAD will be prospectively enrolled. A per-protocol CCT with advanced atherosclerosis analysis will be performed. At the time of CCT a blood sample will be collected for bio-humoral and genetic investigation. The prevalence of high risk atherosclerosis will be quantified, the reclassification rate of CCT vs clinical evaluation evaluated and the potential in vivo association between genetic profile and high risk atherosclerosis explored.
- Conditions
- Coronary Artery Diease
- Being tested
- Cardiac CT
- Keywords
- Cardiac CT, family history of CAD, atherosclerosis, primary prevention
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTDiagnostic test
Cardiac CT with advance plaque evaluation will be performed
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT in primary prevention | Experimental | Patients asymptomatic but with family history of CAD will undergo cardiac CT with advance plaque evaluation Receives: Diagnostic Test: Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk reclassification
Risk reclassification rate will be evaluated
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start3 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DieaseStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cittera, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352111
- Sponsor's protocol ID
- FAMILY Study
- Acronym
- FAMILY
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction; the FAMILY Study
- ClinicalTrials.gov ID
- NCT07352111
- Acronym / sponsor ID
- FAMILY / FAMILY Study
- Conditions
- Coronary Artery Diease
- Keywords
- Cardiac CT, family history of CAD, atherosclerosis, primary prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 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.
The evidence of high-risk atherosclerosis at cardiac CT (CCT) may support aggressive primary prevention treatment, reducing the risk of future cardiovascular events. Family history of coronary artery disease (CAD) is a risk factor for cardiovascular events but limited data described the prevalence of coronary atherosclerosis in these patients.
Aims of the FAMILY project are to explore the prevalence of high-risk coronary atherosclerosis among patients with family history of CAD, to explore whether CCT in this setting may to reclassify patients' vs standard of care and to explore correlations between genetic background and high risk and potentially unstable coronary atherosclerosis.
A consecutive cohort of asymptomatic of patients with family history of CAD will be prospectively enrolled. A per-protocol CCT with advanced atherosclerosis analysis will be performed. At the time of CCT a blood sample will be collected for bio-humoral and genetic investigation. The prevalence of high risk atherosclerosis will be quantified, the reclassification rate of CCT vs clinical evaluation evaluated and the potential in vivo association between genetic profile and high risk atherosclerosis explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT in primary prevention | Experimental | Diagnostic Test: Cardiac CTPatients asymptomatic but with family history of CAD will undergo cardiac CT with advance plaque evaluation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with postive family history of CAD
Key exclusion criteria (2 listed)
- known cardiovascular diseases
- any symptoms
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 |
|---|---|---|
| Cardiac CTCardiac CT with advance plaque evaluation will be performed | Diagnostic test | Cardiac CT in primary prevention |
Primary outcome
Risk reclassification
Time frame: 3 years
Risk reclassification rate will be evaluated
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT in people with Coronary Artery Diease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 1 inclusion and 2 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 21 Jan 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 Elena Cittera (0039 02 83502227, direzionescientifica.ogsa@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk reclassification (time frame: 3 years). 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 21 Jan 2026.