NCT07312565

Brief Summary

Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described. Screening for aortic aneurysms (AA) in patients with intracranial aneurysms (IA) or aneurysmal subarachnoid haemorrhage (aSAH) could be cost-effective and of significant importance to decrease morbidity and mortality. The available literature on the association between the two types of aneurysms is sparse and in general of poor methodological quality. This protocol presents a study to more adequately evaluate the association between IA and AA. Objective: To investigate the occurrence of abdominal aortic aneurysms (AAA) in patients who experienced aSAH. Study design: This single cohort prospective study will include patients who experienced aSAH. The study participants will receive an abdominal ultrasound of the aorta to detect an AAA. Study population: aSAH patients from a prospective cohort trial in the Netherlands. Main study parameters/endpoints: The primary outcome, which will be investigated in the here above described study population, is the number of AAA detected on abdominal ultrasound. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will not receive an intervention, but only a diagnostic imaging without radiation. The burden associated with this study are considered minimal and the risks negligible. An abdominal ultrasound is a non-invasive diagnostic method with no risks for the participant. The only possible existing burden to the participant is travel and appointment time with a risk of detecting an abdominal aortic aneurysm or other (occult) intra-abdominal pathologies. When an aneurysm, sub-aneurysm or other intra-abdominal pathology is detected, surveillance or treatment according to standard of care and guidelines will follow.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

December 2, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

abdominal aortic aneurysmaneurysmal subarachnoid hemorrhageruptured intracranial aneurysmprospective single cohort studyultrasound

Outcome Measures

Primary Outcomes (1)

  • Occurrence of AAA

    Main study parameter/endpoint The primary endpoint of this study will be the occurrence rate of AAA in the study population. This occurrence rate will be calculated as the proportion of all performed ultrasounds in the study group (N; %).

    1 year

Secondary Outcomes (1)

  • Risk factors for AAA in aSAH patients

    1 year

Study Arms (1)

Patients with aSAH from the SPARTA trial

All aSAH patients from a large prospective cohort trial in the Netherlands will be screened for eligibility(12). The Study on Prognosis of Acutely RupTured Aneurysms (SPARTA) is an observational prospective cohort trial conducted in the Netherlands in several clinical centres. The aim of this study is to evaluate the long-term clinical outcome of aSAH patients who underwent neurosurgical- or endovascular treatment for their ruptured IA. The study has a population of around 900 patients. Because of the lethality of aSAH, a large proportion of this study population will be diseased or heavily incapacitated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All aSAH patients from a large prospective cohort trial in the Netherlands will be screened for eligibility(12). The Study on Prognosis of Acutely RupTured Aneurysms (SPARTA) is an observational prospective cohort trial conducted in the Netherlands in several clinical centres. The aim of this study is to evaluate the long-term clinical outcome of aSAH patients who underwent neurosurgical- or endovascular treatment for their ruptured IA. The study has a population of around 900 patients. Because of the lethality of aSAH, a large proportion of this study population will be diseased or heavily incapacitated.

You may qualify if:

  • In order to be eligible to participate in this study, a participant must meet all of the following criteria:
  • Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)
  • Written informed consent
  • By being a study subject of the SPARTA trial, the following criteria are applicable:
  • Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)
  • IA related SAH as confirmed with radiological imaging
  • Age 18 years or older at presentation
  • Written informed consent for the SPARTA-trial

You may not qualify if:

  • A potential participant who meets any of the following criteria will be excluded from participation in this study:
  • Patient is not a study subject of the SPARTA trial
  • Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeroen Brouwers, MD, PhD

    Leiden University Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Hamming, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 31, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04