Endocarditis, BacterialNCT05152225
Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort Study
An observational study of Endocarditis, Bacterial and Aneurysm, Intracranial Mycotic, run by the Jeunes en Neuroradiologie Interventionnelle (JENI) research group.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endocarditis, Bacterial, Aneurysm, Intracranial Mycotic
- What is being tested?
- Brain MRI and digital subtraction angiography (DSA)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Jun 2022
- How long will I take part?
- 2 Years
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multicenter, prospective cohort study of infective endocarditis in academic centers where Brain MRI and DSA are performed routinely.
Who may be able to join
- patients with left-sided active infective endocarditis (IE) satisfying modified Duke Criteria,
- patients who underwent both digital subtraction angiography (DSA) and brainMRI (as part of routine care)
- DSA protocol with 3D rotational for both carotids and one vertebral artery
- MRI/MRA standardized protocol including at least: Diffusion, FLAIR, 3D SWI, 3DT1SE and post gadolinium 3DT1SE and 3D TOF (large field: from the vertex to the magnum foramen).
Who cannot join
- uncertain diagnosis of IE by infectious disease consultants
- patients with chronic IE
- MRI performed after the completion of Infectious intracranial aneurysms (IIA) treatment
- MRI performed without contrast injection or complete protocol
- More than 48-hours delay between performing MRI and DSA
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort Study With Systematic MRI and Digital Subtraction Angiography
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
Read the detailed description
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:
- Better estimate the rate of IIA in proved EI.
- Identify MRI markers able to accurately predict (or exclude) IIA.
- What is the impact of different MRI abnormalities on the outcome?
- Capture the real-world management of EI with neurological complications in comprehensive EI centers in France
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.
- Being tested
- Brain MRI, digital subtraction angiography (DSA)
- Keywords
- MRI, digital subtraction angiography
- Medical subject headings
- Endocarditis, Bacterial, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDiagnostic test
Brain MRI performed routinely in patients with EI
digital subtraction angiography (DSA)Diagnostic test
Digital Subtraction Angiography (DSA) performed routinely in patients with EI
| Study group | Role | What they receive |
|---|---|---|
| Infective endocarditis | Infective endocarditis with systematic brain MRI and digital subtraction angiography (DSA) performed routinely. Receives: Diagnostic Test: Brain MRI; Diagnostic Test: digital subtraction angiography (DSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endocarditis, BacterialStudies 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
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- the Jeunes en Neuroradiologie Interventionnelle (JENI) research group
- Sponsor type
- Research network
- Collaborators
- University Hospital, Limoges, Sainte Anne Hospital (Paris)
- Responsible party
- Principal investigator, Basile Kerleroux, the Jeunes en Neuroradiologie Interventionnelle (JENI) research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152225
- Sponsor's protocol ID
- JENI2021IIA
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carneiro TS, Awtry E, Dobrilovic N, Fagan MA, Kimmel S, Weinstein ZM, Cervantes-Arslanian AM. Neurological Complications of Endocarditis: A Multidisciplinary Review with Focus on Surgical Decision Making. Semin Neurol. 2019 Aug;39(4):495-506. doi: 10.1055/s-0039-1688826. Epub 2019 Sep 18.
PubMed 31533190Garcia-Cabrera E, Fernandez-Hidalgo N, Almirante B, Ivanova-Georgieva R, Noureddine M, Plata A, Lomas JM, Galvez-Acebal J, Hidalgo-Tenorio C, Ruiz-Morales J, Martinez-Marcos FJ, Reguera JM, de la Torre-Lima J, de Alarcon Gonzalez A; Group for the Study of Cardiovascular Infections of the Andalusian Society of Infectious Diseases; Spanish Network for Research in Infectious Diseases. Neurological complications of infective endocarditis: risk factors, outcome, and impact of cardiac surgery: a multicenter observational study. Circulation. 2013 Jun 11;127(23):2272-84. doi: 10.1161/CIRCULATIONAHA.112.000813. Epub 2013 May 6.
PubMed 23648777Snygg-Martin U, Gustafsson L, Rosengren L, Alsio A, Ackerholm P, Andersson R, Olaison L. Cerebrovascular complications in patients with left-sided infective endocarditis are common: a prospective study using magnetic resonance imaging and neurochemical brain damage markers. Clin Infect Dis. 2008 Jul 1;47(1):23-30. doi: 10.1086/588663.
PubMed 18491965Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.
PubMed 26373316Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.
PubMed 26320109Iung B, Tubiana S, Klein I, Messika-Zeitoun D, Brochet E, Lepage L, Al-Attar N, Ruimy R, Leport C, Wolff M, Duval X; ECHO-IMAGE Study Group. Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study. Stroke. 2013 Nov;44(11):3056-62. doi: 10.1161/STROKEAHA.113.001470. Epub 2013 Sep 3.
PubMed 24003046Cho SM, Rice C, Marquardt RJ, Zhang LQ, Khoury J, Thatikunta P, Buletko AB, Hardman J, Uchino K, Wisco D; Infective Endocarditis Strokes and Imaging Characteristics (IESIC) group. Magnetic Resonance Imaging Susceptibility-Weighted Imaging Lesion and Contrast Enhancement May Represent Infectious Intracranial Aneurysm in Infective Endocarditis. Cerebrovasc Dis. 2017;44(3-4):210-216. doi: 10.1159/000479706. Epub 2017 Aug 19.
PubMed 28848178Migdady I, Rice CJ, Hassett C, Zhang LQ, Wisco D, Uchino K, Cho SM. MRI Presentation of Infectious Intracranial Aneurysms in Infective Endocarditis. Neurocrit Care. 2019 Jun;30(3):658-665. doi: 10.1007/s12028-018-0654-1.
PubMed 30519794
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort Study With Systematic MRI and Digital Subtraction Angiography
- ClinicalTrials.gov ID
- NCT05152225
- Acronym / sponsor ID
- JENI2021IIA
- Keywords
- MRI, digital subtraction angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- the Jeunes en Neuroradiologie Interventionnelle (JENI) research groupResearch network
- Collaborators
- University Hospital, Limoges, Sainte Anne Hospital (Paris)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Dec 2021 (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 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
Detailed description
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:
- Better estimate the rate of IIA in proved EI.
- Identify MRI markers able to accurately predict (or exclude) IIA.
- What is the impact of different MRI abnormalities on the outcome?
- Capture the real-world management of EI with neurological complications in comprehensive EI centers in France
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infective endocarditis | – | Diagnostic Test: Brain MRI, Diagnostic Test: digital subtraction angiography (DSA)Infective endocarditis with systematic brain MRI and digital subtraction angiography (DSA) performed routinely. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multicenter, prospective cohort study of infective endocarditis in academic centers where Brain MRI and DSA are performed routinely.
Key inclusion criteria (4 listed)
- patients with left-sided active infective endocarditis (IE) satisfying modified Duke Criteria,
- patients who underwent both digital subtraction angiography (DSA) and brainMRI (as part of routine care)
- DSA protocol with 3D rotational for both carotids and one vertebral artery
- MRI/MRA standardized protocol including at least: Diffusion, FLAIR, 3D SWI, 3DT1SE and post gadolinium 3DT1SE and 3D TOF (large field: from the vertex to the magnum foramen).
Key exclusion criteria (5 listed)
- uncertain diagnosis of IE by infectious disease consultants
- patients with chronic IE
- MRI performed after the completion of Infectious intracranial aneurysms (IIA) treatment
- MRI performed without contrast injection or complete protocol
- More than 48-hours delay between performing MRI and DSA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain MRI performed routinely in patients with EI | Diagnostic test | Infective endocarditis |
| digital subtraction angiography (DSA)Digital Subtraction Angiography (DSA) performed routinely in patients with EI | Diagnostic test | Infective endocarditis |
Primary outcome
The assess the occurrence of infectious intracranial aneurysms in proven infective endocarditis
Time frame: 3 months
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.
3 secondary outcomes
To assess the diagnostic performance of MRI markers to detect infectious intracranial aneurysms
Time frame: 3 months
To assess the predictive performance of imaging markers on clinical outcome
Time frame: 2 years
To assess the rate of symptomatic intracranial haemorrhage following heart surgery
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Results publication: PubMed 31533190Carneiro TS, Awtry E, Dobrilovic N, Fagan MA, Kimmel S, Weinstein ZM, Cervantes-Arslanian AM. Neurological Complications of Endocarditis: A Multidisciplinary Review with Focus on Surgical Decision Making. Semin Neurol. 2019 Aug;39(4):495-506. doi: 10.1055/s-0039-1688826. Epub 2019 Sep 18.
- Results publication: PubMed 23648777Garcia-Cabrera E, Fernandez-Hidalgo N, Almirante B, Ivanova-Georgieva R, Noureddine M, Plata A, Lomas JM, Galvez-Acebal J, Hidalgo-Tenorio C, Ruiz-Morales J, Martinez-Marcos FJ, Reguera JM, de la Torre-Lima J, de Alarcon Gonzalez A; Group for the Study of Cardiovascular Infections of the Andalusian Society of Infectious Diseases; Spanish Network for Research in Infectious Diseases. Neurological complications of infective endocarditis: risk factors, outcome, and impact of cardiac surgery: a multicenter observational study. Circulation. 2013 Jun 11;127(23):2272-84. doi: 10.1161/CIRCULATIONAHA.112.000813. Epub 2013 May 6.
- Results publication: PubMed 18491965Snygg-Martin U, Gustafsson L, Rosengren L, Alsio A, Ackerholm P, Andersson R, Olaison L. Cerebrovascular complications in patients with left-sided infective endocarditis are common: a prospective study using magnetic resonance imaging and neurochemical brain damage markers. Clin Infect Dis. 2008 Jul 1;47(1):23-30. doi: 10.1086/588663.
- Results publication: PubMed 26373316Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.
- Results publication: PubMed 26320109Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.
- Results publication: PubMed 24003046Iung B, Tubiana S, Klein I, Messika-Zeitoun D, Brochet E, Lepage L, Al-Attar N, Ruimy R, Leport C, Wolff M, Duval X; ECHO-IMAGE Study Group. Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study. Stroke. 2013 Nov;44(11):3056-62. doi: 10.1161/STROKEAHA.113.001470. Epub 2013 Sep 3.
- Results publication: PubMed 28848178Cho SM, Rice C, Marquardt RJ, Zhang LQ, Khoury J, Thatikunta P, Buletko AB, Hardman J, Uchino K, Wisco D; Infective Endocarditis Strokes and Imaging Characteristics (IESIC) group. Magnetic Resonance Imaging Susceptibility-Weighted Imaging Lesion and Contrast Enhancement May Represent Infectious Intracranial Aneurysm in Infective Endocarditis. Cerebrovasc Dis. 2017;44(3-4):210-216. doi: 10.1159/000479706. Epub 2017 Aug 19.
- Results publication: PubMed 30519794Migdady I, Rice CJ, Hassett C, Zhang LQ, Wisco D, Uchino K, Cho SM. MRI Presentation of Infectious Intracranial Aneurysms in Infective Endocarditis. Neurocrit Care. 2019 Jun;30(3):658-665. doi: 10.1007/s12028-018-0654-1.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocarditis, Bacterial and Aneurysm, Intracranial Mycotic, run by the Jeunes en Neuroradiologie Interventionnelle (JENI) research group.
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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basile Kerleroux, MD-MSc (+33145648222, basile.kerleroux@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assess the occurrence of infectious intracranial aneurysms in proven infective endocarditis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152225, which also lists 8 linked publications.
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 9 Dec 2021.