Skip to main content
OpenTrials
Completed

NCT Number: NCT02252900

Long-term Clinico-radiological Evolution of Patients With 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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Magnetic Resonance Imaging

Other

All patients will undergo the diagnostic test specific to the study

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

    Time frame: 1 day

Secondary outcomes

  1. Rankin scale

    Time frame: 1 day

  2. Karnofsky scale

    Time frame: 1 day

  3. 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

  4. IQCODE

    Time frame: 1 day

  5. SF 36

    Time frame: 1 day

  6. WhOQOL

    Time frame: 1 day

  7. CES-D scale

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis

Acronym: POST-IMAGE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2014
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.