An observational study in Endocarditis, Bacterial and Aneurysm, Intracranial Mycotic, sponsored by the Jeunes en Neuroradiologie Interventionnelle (JENI) research group. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by the Jeunes en Neuroradiologie Interventionnelle (JENI) research group · Observational
The main objective of this study is to better estimate the rate of infectious intracranial aneurysms (IIA) in proved infective endocarditis (IE). It also aims to identify MRI markers capable of accurately predicting (or excluding) IIA; to assess the impact of the different MRI abnormalities on the outcome; to capture the real-world management of EI with neurological complications in comprehensive IE centers in France
Rationale:
The incidence of Infective endocarditis (IE) in developed countries is approximately 3-15 per 100,000 pers-years. Discharge mortality remains 15-30% and therapeutic management suffers in many ways from the paucity of randomized studies.(1) Symptomatic neurological complications, which occur in 15 to 30% of patients, are the most frequent extra-cardiac complication of IE and are deemed to worsen the outcome of EI.(2,3) Among this overall neurological complications, Infectious Intracranial Aneurysms (IIA) are a relatively rare, yet probably underestimate, vessel wall injury caused by septic emboli, with potentially intracranial bleeding for the patients.
Neuroimaging in the context of IE has gained wide acceptance and is encouraged in the current guidelines.(4,5) Nevertheless the benefit of early neuroimaging to optimize the initial therapeutic management remains debated.(6,7) While the appearance and the frequency of the various neurologic complications of EI are well known thanks to prospective cohort studies with systematic pre-therapeutic MRI(8-10), several clinically relevant questions are still unknow or approximate, including: 1/ What is the rate of IIA in proved EI. The current gold standard for the detection of these small and distally located aneurysms remains Digital Subtraction Angiography (DSA) and to our knowledge, there is no prospective unbiased cohort of IE with systematic DSA available in the literature. 2/ Are there MRI signs correlated with the presence of IIA on DSA? Several MRI markers such as sulcal SWI lesion or cerebral microbleeds (CMBs) with contrast enhancement look promising (10), but validation in unbiased prospective studies with systematic MRI and DSA is needed. 3/ What is the impact on the outcome of the different MRI abnormalities and of unruptured and ruptured IIA? As previously mentioned, the value of both MRI and DSA remain unclear to guide the acute therapeutic management of EI. A recent French survey highlighted differences between university Hospital in France in the management of IIA. Thus, the analysis of the current management of EI with neurological complications could also help at informing the design of future randomized trials.
Questions:
Design and setting:
Multi-site, prospective cohort study, with standardized imaging protocol, in academic centers where MRI and DSA are performed routinely in patients with EI.
Ethics:
As for all non-interventional studies of de-identified data, written informed consent will be waived and a commitment to compliance (Reference Methodology CPMR-4) will be filed to the French data protection authority (CNIL) prior to data centralization, in respect to the General Data Protection Regulation. Patients and proxies will be informed they could oppose the use of their data for research purposes.
22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.
This study's planned enrollment of 200 is below the median of 588 across 10 observational studies indexed under Endocarditis, Bacterial.
Browse Endocarditis, Bacterial studies →This is the only study on the registry with the Jeunes en Neuroradiologie Interventionnelle (JENI) research group as lead sponsor.
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Multicenter, prospective cohort study of infective endocarditis in academic centers where Brain MRI and DSA are performed routinely.
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Exclusion Criteria:
Infective endocarditis with systematic brain MRI and digital subtraction angiography (DSA) performed routinely.
Diagnostic Test: Brain MRI · Diagnostic Test: digital subtraction angiography (DSA)
Brain MRI performed routinely in patients with EI
Digital Subtraction Angiography (DSA) performed routinely in patients with EI
The assess the occurrence of infectious intracranial aneurysms in proven infective endocarditis
In all included cases, infectious intracranial aneurysms will be detected using cerebral Digital Subtraction Angiography (DSA), which remains the current gold standard for the detection of these small and distally located aneurysms. DSA protocol will include 2D and 3D rotational acquisitions on both carotid arteries and one vertebral artery. The number of infective endocarditis with infectious intracranial aneurysms will be referred to the total number of endocarditis to estimate the incidence of these cerebral anomalies.
Time frame: 3 months
To assess the diagnostic performance of MRI markers to detect infectious intracranial aneurysms
Logistic regression and Linear Discriminant Analysis (LDA) methods will be used to identify the most relevant MRI signs to predict or exclude IIA (on DSA).
Time frame: 3 months
To assess the predictive performance of imaging markers on clinical outcome
Logistic regression will be used to identify MRI and DSA sign associated with neurological worsening at follow-up.
Time frame: 2 years
To assess the rate of symptomatic intracranial haemorrhage following heart surgery
In case of neurological deterioration after cardiac surgery, brain imaging (MRI or NCCT) will be performed to detect the occurrence or progression of cerebral haemorrhage. Logistic regression will be used to identify the MRI and DSA signs associated with this neurological complication.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2022; primary completion for Mar 2022, 2 months later.
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This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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