Infectious EndocarditisPOST-IMAGENCT02252900
Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis
A study testing Magnetic resonance imaging in people with Infectious Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Endocarditis
- What is being tested?
- Magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2013to 6 Jul 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Infective endocarditis treated in Bichat Claude Bernard hospital
- Cerebral MRI performed during the acute phase of endocarditis
- Resident in Metropolitan France
- 18 years old or more
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis
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).
Read the detailed description
Introduction:
Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor prognosis (20 % of mortality). Neurological complications participate in the initial morbimortality but their long-term impact is poorly known. The acute neurological complications are symptomatic in approximately a quarter of patients. Neurological lesions are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are not known.
Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious endocarditis may involve and may have an impact on functional prognosis.
Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing the proportion of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).
Secondary objectives:
- To compare frequency of different brain damages in acute phase of IE and during follow-up.
- To analyse the relationship between functional and cognitive status and cerebral lesions.
- To analyse the relationship between initial and follow-up cerebral lesions and initials characteristics (microorganisms, anticoagulation, echocardiographic characteristics, valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)
- To collect plasma during follow-up of IE
- To compare patient characteristics between patients who accept the functional exploration and those who patient refuse
- To describe oral health and oral condition
- Conditions
- Infectious Endocarditis
- Being tested
- Magnetic resonance imaging
- Keywords
- Brain damages, MRI, infectious endocarditis
- Medical subject headings
- Endocarditis, Subacute Bacterial, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
All patients will undergo the diagnostic test specific to the study
| Study group | Role | What they receive |
|---|---|---|
| cerebral MRI during follow-up of IE | Experimental | All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging) Receives: Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (7)
Rankin scale
Measured: 1 day
Karnofsky scale
Measured: 1 day
Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)
Measured: 1 day
IQCODE
Measured: 1 day
SF 36
Measured: 1 day
WhOQOL
Measured: 1 day
CES-D scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study start12 Dec 2013
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infectious EndocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard IUNG, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252900
- Sponsor's protocol ID
- P120901
- Other IDs
- CRC12019
- Acronym
- POST-IMAGE
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2013
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36797077Creuzet 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.
PubMed 40716613
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT02252900
- Acronym / sponsor ID
- POST-IMAGE / P120901
- Conditions
- Infectious Endocarditis
- Keywords
- Brain damages, MRI, infectious endocarditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 30 Sep 2014 (estimated)
- 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.
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).
Detailed description
Introduction:
Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor prognosis (20 % of mortality). Neurological complications participate in the initial morbimortality but their long-term impact is poorly known. The acute neurological complications are symptomatic in approximately a quarter of patients. Neurological lesions are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are not known.
Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious endocarditis may involve and may have an impact on functional prognosis.
Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing the proportion of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).
Secondary objectives:
- To compare frequency of different brain damages in acute phase of IE and during follow-up.
- To analyse the relationship between functional and cognitive status and cerebral lesions.
- To analyse the relationship between initial and follow-up cerebral lesions and initials characteristics (microorganisms, anticoagulation, echocardiographic characteristics, valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)
- To collect plasma during follow-up of IE
- To compare patient characteristics between patients who accept the functional exploration and those who patient refuse
- To describe oral health and oral condition
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral MRI during follow-up of IE | Experimental | Other: Magnetic resonance imagingAll patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of Infective endocarditis treated in Bichat Claude Bernard hospital
- Cerebral MRI performed during the acute phase of endocarditis
- Resident in Metropolitan France
- 18 years old or more
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Magnetic resonance imagingAll patients will undergo the diagnostic test specific to the study | Other | cerebral MRI during follow-up of IE |
Primary outcome
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
Time frame: 1 day
7 secondary outcomes
Rankin scale
Time frame: 1 day
Karnofsky scale
Time frame: 1 day
Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)
Time frame: 1 day
IQCODE
Time frame: 1 day
SF 36
Time frame: 1 day
WhOQOL
Time frame: 1 day
CES-D scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 36797077Celestin 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.
- Results publication: PubMed 40716613Creuzet 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.
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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.
Bernard IUNG, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging in people with Infectious Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 day). 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 NCT02252900, which also lists 2 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 20 Mar 2026.