Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)

Inclusion at least one year after aSAH

Written informed consent

Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)

Disqualifiers

Patient is not a study subject of the SPARTA trial

Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

233 Participants
are grouped into 1 trial group
Group A: Patients with aSAH from the SPARTA trial

Trial outcomes

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; %).

Time frame
1 year

Secondary outcomes

1

Risk factors for AAA in aSAH patients

Secondary study parameters/endpoint As a secondary endpoint, the investigators will evaluate risk factors of having an AAA as an aSAH patient. Presence of these factors (i.e. smoking, aneurysmal disease in medical history, age, gender) will be calculated as the proportion of the total study population (N; %).

Time frame
1 year

Other outcomes

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