Intracranial AneurysmsSIRENNCT07387575
Screening in Relatives With Elevated Risk for Unruptured Intracranial Aneurysms
An observational study of Intracranial Aneurysms and Subarachnoid Hemorrhage, Aneurysmal, run by University of Novi Sad at 1 site in Serbia.
Trial summary
The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms, Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 300 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Feb 2026to 31 Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll first-degree relatives of patients with aneurysmal stroke who are aged 30 years or older, current smokers or have hypertension and individuals with sporadic UIAs and no past family history of aneurysmal stroke or UIAs. Participants must be able to undergo magnetic resonance angiography (MRA) and provide informed consent. Individuals with a prior intracranial aneurysm rupture, contraindications to MRI/MRA, pregnancy, or history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia.
Who may be able to join
- First-degree relatives (parents, siblings, or children) of patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH);
- Age ≥ 30 years at the time of enrollment, and current cigarette smokers or diagnosed with hypertension (either treated or untreated);
- Able and willing to undergo magnetic resonance angiography (MRA);
- 5. Able to provide written informed consent; 6. Sporadic aneurysm subjects must have a confirmed UIAs
Who cannot join
- History of intracranial aneurysm rupture or prior subarachnoid hemorrhage;
- Contraindications to MRI/MRA (e.g., pacemaker, metallic implants, severe claustrophobia) or pregnancy (due to MRI safety considerations);
- A history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia;
- Unable or unwilling to provide informed consent;
- Participation in another interventional study that could interfere with outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site
University Clinical Center of Vojvodina
Novi Sad, Vojvodina, 21137
About this study
Official title: Screening for Intracranial Unruptured Aneurysms in First-Degree Relatives of Patients With Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms. This study aims to identify individuals who are at increased risk and determine the effect of environmental factors for development of unruptured intracranial aneurysms.
Read the detailed description
The prevalence of intracranial aneurysms is 3-5% according to studies, while the annual incidence of complications in the form of bleeding from an intracranial aneurysm is 8-10 per 100 000 people. Subarachnoid hemorrhage is an urgent condition characterized by the extravasation of blood into the space surrounding the central nervous system, which is filled with cerebrospinal fluid. The leading cause of non-traumatic subarachnoid hemorrhage is the rupture of an intracranial aneurysm, accounting for approximately 80-85% of cases, and it is associated with a high rate of complications and mortality. Therefore, early detection of patients at elevated risk, monitoring, and management of unruptured intracranial aneurysms is of paramount importance.
Data suggest that first-degree relatives of a family member affected have higher risk for developing intracranial aneurysm. Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms is research effort of neurosurgeons and neuroradiologists to identify environmental factors in study population of Vojvodina (Serbia), that contribute to development of intracranial aneurysms. This study will involve at least 150 siblings (first-degree relatives) of patients who suffered aneurysmal stroke, and determine effect of demographics, environmental factors including, smoking, medical comorbidities and hypertension, caffeinated drink consumption, and hard physical work on the development of unruptured intracranial aneurysms (UIAs). This study of affected families and individuals, known as Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms (SIREN) study, is sponsored by Provincial Secretariat of Health of the Autonomous Province of Vojvodina (Special Screening Program).
This study will also involve at least 150 individuals with no past family history of aneurysmal stroke or UIAs. SIREN study will take part in Autonomous Province in Vojvodina only.
In order to be eligible for the study, individuals with affected family member that was admitted to study center for aneurysmal stroke, had to be older than 30 years of age, and first-degree relatives (father, mother, sister, brother, daughter, or son).
Participants will be asked to complete informed consent and questionnaire with past medical and family history. After completing questionnaires, their arterial blood pressure will be measured. Participants will receive no monetary compensation for participation.
Identification of demographic and environmental risk factors contributing to development of UIAs in families of affected individuals may result in early detection of ones at risk and potentially prevent formation of UIAs or complications including aneurysmal stroke.
- Keywords
- Stroke, Intracranial Aneurysm, Brain Aneurysm, Familial Intracranial Aneurysm, Aneurysmal Subarachnoid Hemorrhage
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 150 individuals that are first-degree relatives of affected patients admitted to study center for aneurysmal stroke and 150 individuals with sporadic UIAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of unruptured intracranial aneurysms by magnetic resonance angiography (MRA).
The proportion of screened first-degree relatives (aged ≥30) who are found to have one or more UIAs.
Measured: At the time of screening (single MRA examination)
Secondary outcomes (4)
Correlation of aneurysm presence with risk factors
Analysis of the association between demographic and environmental (e.g., age, ethnicity, cigarette smoking, hypertension, consumption of caffeinated drinks, etc.) and the presence of UIAs.
Measured: At the time of screening
Aneurysm size and location
Characterization of detected aneurysms by maximal size (millimeters) and anatomical location within the cerebral vasculature.
Measured: At the time of screening
Prevalence of multiple aneurysms
Proportion of participants with multiple intracranial aneurysms (MIAs) detected on MRA. MIAs are defined as more than one UIAs in one patient.
Measured: At the time of screening
Assessment of anatomical variations of cerebral arteries
Identification and classification of anatomical variations (e.g., vessel hypoplasia, fenestrations, duplicated arteries, circle of Willis variations, etc.) and evaluation of their association with the presence of UIAs.
Measured: At the time of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Center of Vojvodina
- Responsible party
- Principal investigator, Nebojsa Lasica, University of Novi Sad
- Investigators
- Nebojsa M Lasica, M.D., Principal investigator, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387575
- Sponsor's protocol ID
- 00-18
- Acronym
- SIREN
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Intracranial Unruptured Aneurysms in First-Degree Relatives of Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT07387575
- Acronym / sponsor ID
- SIREN / 00-18
- Keywords
- Stroke, Intracranial Aneurysm, Brain Aneurysm, Familial Intracranial Aneurysm, Aneurysmal Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Collaborators
- Clinical Center of Vojvodina
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms. This study aims to identify individuals who are at increased risk and determine the effect of environmental factors for development of unruptured intracranial aneurysms.
Detailed description
The prevalence of intracranial aneurysms is 3-5% according to studies, while the annual incidence of complications in the form of bleeding from an intracranial aneurysm is 8-10 per 100 000 people. Subarachnoid hemorrhage is an urgent condition characterized by the extravasation of blood into the space surrounding the central nervous system, which is filled with cerebrospinal fluid. The leading cause of non-traumatic subarachnoid hemorrhage is the rupture of an intracranial aneurysm, accounting for approximately 80-85% of cases, and it is associated with a high rate of complications and mortality. Therefore, early detection of patients at elevated risk, monitoring, and management of unruptured intracranial aneurysms is of paramount importance.
Data suggest that first-degree relatives of a family member affected have higher risk for developing intracranial aneurysm. Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms is research effort of neurosurgeons and neuroradiologists to identify environmental factors in study population of Vojvodina (Serbia), that contribute to development of intracranial aneurysms. This study will involve at least 150 siblings (first-degree relatives) of patients who suffered aneurysmal stroke, and determine effect of demographics, environmental factors including, smoking, medical comorbidities and hypertension, caffeinated drink consumption, and hard physical work on the development of unruptured intracranial aneurysms (UIAs). This study of affected families and individuals, known as Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms (SIREN) study, is sponsored by Provincial Secretariat of Health of the Autonomous Province of Vojvodina (Special Screening Program).
This study will also involve at least 150 individuals with no past family history of aneurysmal stroke or UIAs. SIREN study will take part in Autonomous Province in Vojvodina only.
In order to be eligible for the study, individuals with affected family member that was admitted to study center for aneurysmal stroke, had to be older than 30 years of age, and first-degree relatives (father, mother, sister, brother, daughter, or son).
Participants will be asked to complete informed consent and questionnaire with past medical and family history. After completing questionnaires, their arterial blood pressure will be measured. Participants will receive no monetary compensation for participation.
Identification of demographic and environmental risk factors contributing to development of UIAs in families of affected individuals may result in early detection of ones at risk and potentially prevent formation of UIAs or complications including aneurysmal stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –150 individuals that are first-degree relatives of affected patients admitted to study center for aneurysmal stroke and 150 individuals with sporadic UIAs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll first-degree relatives of patients with aneurysmal stroke who are aged 30 years or older, current smokers or have hypertension and individuals with sporadic UIAs and no past family history of aneurysmal stroke or UIAs. Participants must be able to undergo magnetic resonance angiography (MRA) and provide informed consent. Individuals with a prior intracranial aneurysm rupture, contraindications to MRI/MRA, pregnancy, or history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia.
Key inclusion criteria (4 listed)
- First-degree relatives (parents, siblings, or children) of patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH);
- Age ≥ 30 years at the time of enrollment, and current cigarette smokers or diagnosed with hypertension (either treated or untreated);
- Able and willing to undergo magnetic resonance angiography (MRA);
- 5. Able to provide written informed consent; 6. Sporadic aneurysm subjects must have a confirmed UIAs
Key exclusion criteria (5 listed)
- History of intracranial aneurysm rupture or prior subarachnoid hemorrhage;
- Contraindications to MRI/MRA (e.g., pacemaker, metallic implants, severe claustrophobia) or pregnancy (due to MRI safety considerations);
- A history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia;
- Unable or unwilling to provide informed consent;
- Participation in another interventional study that could interfere with outcomes.
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
Detection of unruptured intracranial aneurysms by magnetic resonance angiography (MRA).
Time frame: At the time of screening (single MRA examination)
The proportion of screened first-degree relatives (aged ≥30) who are found to have one or more UIAs.
4 secondary outcomes
Correlation of aneurysm presence with risk factors
Time frame: At the time of screening
Aneurysm size and location
Time frame: At the time of screening
Prevalence of multiple aneurysms
Time frame: At the time of screening
Assessment of anatomical variations of cerebral arteries
Time frame: At the time of screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- 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.
Nebojsa M Lasica, M.D. principal investigator
University of Novi Sad
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 Intracranial Aneurysms and Subarachnoid Hemorrhage, Aneurysmal, run by University of Novi Sad at 1 site in Serbia.
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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. 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 Serbia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection of unruptured intracranial aneurysms by magnetic resonance angiography (MRA). (time frame: At the time of screening (single MRA examination)). 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 4 Feb 2026.