Coronary Artery Disease (CAD)NCT07172308
High Risk Atherosclerosis Identified at Cardiac CT Among Patients With vs Without Family History of CAD
An observational study of Coronary Artery Disease (CAD) and Atherosclerosis of Coronary Artery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Atherosclerosis of Coronary Artery
- How many people
- 480 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Jan 2025
- Primary completion15 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
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
- NCT07172308
- Sponsor's protocol ID
- FRATER Study
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Atherosclerosis Identified at Cardiac CT Among Patients With vs Without Family History of CAD
- ClinicalTrials.gov ID
- NCT07172308
- Acronym / sponsor ID
- FRATER Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 15 Sep 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of high risk atherosclerosis at coronary computed tomography angiography (CCTA)
Time frame: Day 1
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Atherosclerosis of Coronary Artery, 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 15 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of high risk atherosclerosis at coronary computed tomography angiography (CCTA) (time frame: Day 1). 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 15 Sep 2025.