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

NCT07172308 | Completed

• 1 other identifier: FRATER Study
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identification of high risk atherosclerosis at coronary computed tomography angiography (CCTA)

  the present is a trasveral descriptive study. No follow-up will be performed and all parameters will be evaluated at the time of CCTA acquisition (Day 1)

  Day 1

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

History of any adverse reaction to contrast medium * History of any severe allergic reactions * Previous history of chronic kidney disease (eGFR\<30 ml/min/1.73m2) * Previous history of cardiovascular disease, including documented asymptomatic atherosclerosis

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Scientific Direction

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 15, 2025
• Study Start: January 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: August 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)