NCT02252900

Brief Summary

Primary objective: To describe the evolution of cerebral lesions in IE patients (number of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

December 19, 2013

Last Update Submit

March 17, 2026

Conditions

Infectious Endocarditis

Keywords

Brain damagesMRIinfectious endocarditis

Outcome Measures

Primary Outcomes (1)

  • Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit

    1 day

Secondary Outcomes (7)

  • Rankin scale

    1 day

  • Karnofsky scale

    1 day

  • Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)

    1 day

  • IQCODE

    1 day

  • SF 36

    1 day

  • +2 more secondary outcomes

Study Arms (1)

cerebral MRI during follow-up of IE

EXPERIMENTAL

All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)

Other: Magnetic resonance imaging

Interventions

Magnetic resonance imagingOTHER

All patients will undergo the diagnostic test specific to the study

cerebral MRI during follow-up of IE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of Infective endocarditis treated in Bichat Claude Bernard hospital
  • Cerebral MRI performed during the acute phase of endocarditis
  • Resident in Metropolitan France
  • years old or more

You may not qualify if:

  • Refusal to participate
  • Contra indication to MRI scan
  • History of allergy to gadolinium
  • Pregnancy or lactating female
  • Lack of Social Security or CMU (recipient or beneficiary)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Bichat - Claude Bernard

Paris, 75018, France

Location

Related Publications (2)

  • Celestin B, Habensus EI, Tubiana S, Preau M, Millot S, Lescure FX, Kerneis C, Para M, Duval X, Iung B; POST-IMAGE study group. Determinants of adherence to oral hygiene prophylaxis guidelines in patients with previous infective endocarditis. Arch Cardiovasc Dis. 2023 Apr;116(4):176-182. doi: 10.1016/j.acvd.2023.01.003. Epub 2023 Jan 31.

    PMID: 36797077RESULT

  • Creuzet G, Boukobza M, Habensus EI, Lalloue B, Preau M, Alfaiate T, Peiffer-Smadja N, Mazighi M, Tubiana S, Laissy JP, Iung B, Duval X, Sonneville R; POST-IMAGE study group. Long-term evolution and functional impact of cerebral lesions detected by systematic brain magnetic resonance imaging in patients with infective endocarditis: the POST-IMAGE prospective cohort. J Infect. 2025 Sep;91(3):106560. doi: 10.1016/j.jinf.2025.106560. Epub 2025 Jul 25.

    PMID: 40716613RESULT

MeSH Terms

Conditions

Endocarditis, Subacute BacterialBrain Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Endocarditis, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsCardiovascular InfectionsCardiovascular DiseasesEndocarditisHeart DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Bernard IUNG, Professor

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

September 30, 2014

Study Start

December 12, 2013

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

FR(1)