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IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, September 2005
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00144885
  Purpose

Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.


Condition Intervention
Endocarditis, Bacterial
Behavioral: Modification of therapy

MedlinePlus related topics: Endocarditis
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Modification of therapeutic project [ Time Frame: As soon as RMI is performed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modification of diagnostic classification (Duke modified criteria) [ Time Frame: As soon as RMI is performed ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention Behavioral: Modification of therapy
Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results

Detailed Description:

Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

Resonance magnetic imaging (head and abdomen) will be performed systematically before Day 7.

The impact on the diagnosis and therapeutic options will be assessed, as compared to pre resonance magnetic nuclear (RMN) imaging declaration.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute phase of infective endocarditis

Exclusion Criteria:

  • Contra indication to RMN
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144885

Contacts
Contact: Xavier Duval, MD/PhD 33 1 40 25 71 35 xavier.duval@bch.aphp.fr

Locations
France
Hôpital Bichat Claude Bernard, 46 rue Henri Huchard Recruiting
Paris, France, 75877
Contact: Xavier Duval, MD/PhD     33 1 40 25 71 48     xavier.duval@bch.aphp.fr    
Principal Investigator: Xavier Duval, MD/PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Duval Hôpital Bichat, Assistance Publique Hôpitaux de Paris
  More Information

Responsible Party: Department Clinical Research of Developpement ( Zakia IDIR )
Study ID Numbers: P040431
Study First Received: September 2, 2005
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00144885  
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Endocarditis
RMI
Impact measure

Study placed in the following topic categories:
Bacterial Infections
Heart Diseases
Endocarditis, Bacterial
Cardiovascular Infections
Endocarditis

Additional relevant MeSH terms:
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009