High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction

NCT07352111 | Recruiting DMC

• 1 other identifier: FAMILY Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Cardiac CT; family history of CAD; atherosclerosis; primary prevention

Outcome Measures

Primary Outcomes (1)

• Risk reclassification

  Risk reclassification rate will be evaluated

  3 years

Study Arms (1)

Cardiac CT in primary prevention

EXPERIMENTAL

Patients asymptomatic but with family history of CAD will undergo cardiac CT with advance plaque evaluation

Diagnostic Test: Cardiac CT

Interventions

Cardiac CT DIAGNOSTIC_TEST

Cardiac CT with advance plaque evaluation will be performed

Cardiac CT in primary prevention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with postive family history of CAD

You may not qualify if:

• known cardiovascular diseases
• any symptoms

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Ospedale Galeazzi-Sant'Ambrogio IRCCS

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Elena Cittera

CONTACT

0039 02 83502227; direzionescientifica.ogsa@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)