Clinical Trial: Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary:

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 duri
  Sponsor: Assistance Publique - Hôpitaux de Paris
  

  Current 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 ]
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • 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 ]
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Assistance Publique - Hôpitaux de Paris
  

  Dates:
  Date Received: December 19, 2013
  Date Started: December 2013
  Date Completion: March 2018
  Last Updated: May 9, 2016
  Last Verified: May 2016