Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort Study

NCT05152225 | Unknown

• 1 other identifier: JENI2021IIA
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 the real-world management of EI with neurological complications in comprehensive IE centers in France

Conditions

Endocarditis, Bacterial; Aneurysm, Intracranial Mycotic

Keywords

MRI; digital subtraction angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• To assess the diagnostic performance of MRI markers to detect infectious intracranial aneurysms

  3 months

• To assess the predictive performance of imaging markers on clinical outcome

  2 years

• To assess the rate of symptomatic intracranial haemorrhage following heart surgery

  6 months

Study Arms (1)

Infective endocarditis

Infective endocarditis with systematic brain MRI and digital subtraction angiography (DSA) performed routinely.

Diagnostic Test: Brain MRI; Diagnostic Test: digital subtraction angiography (DSA)

Interventions

Brain MRI DIAGNOSTIC_TEST

Brain MRI performed routinely in patients with EI

Infective endocarditis

digital subtraction angiography (DSA) DIAGNOSTIC_TEST

Digital Subtraction Angiography (DSA) performed routinely in patients with EI

Infective endocarditis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicenter, prospective cohort study of infective endocarditis in academic centers where Brain MRI and DSA are performed routinely.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• the Jeunes en Neuroradiologie Interventionnelle (JENI) research group: lead
• University Hospital, Limoges: collaborator
• Sainte Anne Hospital (Paris): collaborator

Related Publications (8)

• 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.

  PMID: 31533190 RESULT

• Garcia-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.

  PMID: 23648777 RESULT

• Snygg-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.

  PMID: 18491965 RESULT

• Baddour 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.

  PMID: 26373316 RESULT

• Habib 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.

  PMID: 26320109 RESULT

• Iung 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.

  PMID: 24003046 RESULT

• Cho 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.

  PMID: 28848178 RESULT

• Migdady 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.

  PMID: 30519794 RESULT

MeSH Terms

Conditions

Endocarditis, Bacterial; Intracranial Aneurysm

Interventions

Angiography, Digital Subtraction

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiographic Image Enhancement; Image Enhancement; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Subtraction Technique; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Basile Kerleroux, MD-MSc

CONTACT

+33145648222; basile.kerleroux@gmail.com

Géraud Forestier, MD-MSc

CONTACT

+33145648222; geraudforestier@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-MSc

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2022
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share