High Risk Atherosclerosis Identified at Cardiac CT Among Patients With vs Without Family History of CAD

NCT ID: NCT07172308

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-08-01

Brief Summary

Acute coronary syndrome often represtent the first drammatic manifestation of coronary atherosclerosis.

Cardiac computed tomography angiography (CCTA) has recently gained a pivotal role in the evalution of patients with suspected coronary artery disease (CAD). Of inteterst, it may provide important information on coronary atherosclerosis beyond lumen stenosis; more precisely high risk plaque features could be identified even in the abesence of significative lumen stenosis (i.e. not flow-limiting lesions).

The evidence of non-obstructive but high risk atheroscleorisis may support aggressive primary prevention treatment, reducing the risk of future cardiovascular events. Even if familty history of CAD is considered a risk factor for cardiovascular events, no clear data are available regarding the prevalence of coronary atherosclerosis in this subgroup of patients and CCTA in asymptomatic subjects is not clearly supported by evidence nor suggested by guidelines.

Aim of our study is to explore whether the prevalence of high risk coronary atherosclerosis among patients with family hystory of CAD is different when compared with a group of patients without family hystory of CAD.

For that purpose from consecutive registry of patient who underwent clinically indicated CCTA for suspected but unknown CAD a cohort of patients with family history of CAD as first early presentation of coronary atherosclerosis (group 1) will be compared with a consecutive cohort of subjects without familiy history of CAD (group 2). All CCTA will be perfomed according to most recent guidelines and advanced atheroscleoris analysis will be performed. As primary objective of the study, the prevalence of high risk atherosclerosis will be compared between the two Groups.

The evidence of higher prevalence of high-risk atherosclerosis prevalence in group 1 vs group 2 may further support the use of CCTA in asymptomatic patients but with family history of CAD.

Conditions

Coronary Artery Disease (CAD); Atherosclerosis of Coronary Artery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Group 1
• Patients with clinical indation to CCTA for suspected CAD with family history of CAD
• Age >40 years old for male and >50 years old for female
• No history of previous cardiovascular disease Group 2
• Patients with clinical indation to CCTA for suspected CAD without family history of CAD
• Age >40 years old for male and >50 years old for female
• No history of previous cardiovascular disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Elena Cittera

Head Scientific Direction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, , Italy

Countries

Italy

Other Identifiers

FRATER Study

Identifier Type: -

Identifier Source: org_study_id