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IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00144885
First received: September 2, 2005
Last updated: February 11, 2009
Last verified: September 2005
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact

Resource links provided by NLM:

MedlinePlus related topics: Endocarditis
U.S. FDA Resources

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 ]

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

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

Locations
France
Hôpital Bichat Claude Bernard, 46 rue Henri Huchard
Paris, France, 75877
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Duval Hôpital Bichat, Assistance Publique Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zakia IDIR, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00144885     History of Changes
Other Study ID Numbers: P040431
Study First Received: September 2, 2005
Last Updated: February 11, 2009
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
 Bacterial Infections
Cardiovascular Infections
Infection

ClinicalTrials.gov processed this record on May 21, 2013