Recruiting
FAMILY

Exploration of High-risk Coronary Atherosclerosis in Patients with Family History of CAD

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cardiac CT

Diagnostic Test
Who is being recruted

Arterial Occlusive Diseases
+2

+ Arteriosclerosis
+ Cardiovascular Diseases
From 40 to 70 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study ContactElena Cittera
Last updated: January 22, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 3, 2025Actual date on which the first participant was enrolled.

This study, known as the FAMILY Study, focuses on individuals with a family history of coronary artery disease (CAD), a condition where the blood supply to the heart is reduced due to narrowed or blocked arteries. The goal is to understand the prevalence of high-risk atherosclerosis, a buildup of fats, cholesterol and other substances in and on the artery walls, which can lead to cardiovascular events. The study aims to explore whether advanced imaging techniques like cardiac CT (CCT) can help in better understanding the risk and improving prevention strategies, as well as investigating potential links between genetic background and high-risk atherosclerosis. In this study, a group of individuals without symptoms but with a family history of CAD will be enrolled. They will undergo a detailed CCT scan to analyze the state of their arteries. Additionally, a blood sample will be collected for further bio-humoral and genetic investigation. The study will measure the prevalence of high-risk atherosclerosis, evaluate how the CCT scan results compare to standard clinical evaluations, and explore potential links between genetic profiles and high-risk atherosclerosis.

Official TitleHigh-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction; the FAMILY Study 
NCT07352111
Principal SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study ContactElena Cittera
Last updated: January 22, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 40 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases
Atherosclerosis
Criteria
1 inclusion criteria required to participate
patients with postive family history of CAD
2 exclusion criteria prevent from participating
known cardiovascular diseases
any symptoms

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients asymptomatic but with family history of CAD will undergo cardiac CT with advance plaque evaluation

Cardiac CT with advance plaque evaluation will be performed
Study Objectives
Primary Objectives

Risk reclassification rate will be evaluated

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Ospedale Galeazzi-Sant'Ambrogio IRCCSMilan, ItalySee the location
Recruiting
One Study Center