- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144885
IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis (IMAGE)
February 11, 2009 updated by: Assistance Publique - Hôpitaux de Paris
Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact
Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75877
- Hôpital Bichat Claude Bernard, 46 rue Henri Huchard
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute phase of infective endocarditis
Exclusion Criteria:
- Contra indication to RMN
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
|
Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modification of therapeutic project
Time Frame: As soon as RMI is performed
|
As soon as RMI is performed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modification of diagnostic classification (Duke modified criteria)
Time Frame: As soon as RMI is performed
|
As soon as RMI is performed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xavier Duval, Hôpital Bichat, Assistance Publique Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mahr A, Batteux F, Tubiana S, Goulvestre C, Wolff M, Papo T, Vrtovsnik F, Klein I, Iung B, Duval X; IMAGE Study Group. Brief report: prevalence of antineutrophil cytoplasmic antibodies in infective endocarditis. Arthritis Rheumatol. 2014 Jun;66(6):1672-7. doi: 10.1002/art.38389.
- Iung B, Tubiana S, Klein I, Messika-Zeitoun D, Brochet E, Lepage L, Al-Attar N, Ruimy R, Leport C, Wolff M, Duval X; ECHO-IMAGE Study Group. Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study. Stroke. 2013 Nov;44(11):3056-62. doi: 10.1161/STROKEAHA.113.001470. Epub 2013 Sep 3.
- Iung B, Klein I, Mourvillier B, Olivot JM, Detaint D, Longuet P, Ruimy R, Fourchy D, Laurichesse JJ, Laissy JP, Escoubet B, Duval X; Study Group. Respective effects of early cerebral and abdominal magnetic resonance imaging on clinical decisions in infective endocarditis. Eur Heart J Cardiovasc Imaging. 2012 Aug;13(8):703-10. doi: 10.1093/ehjci/jes023. Epub 2012 Feb 14.
- Duval X, Iung B, Klein I, Brochet E, Thabut G, Arnoult F, Lepage L, Laissy JP, Wolff M, Leport C; IMAGE (Resonance Magnetic Imaging at the Acute Phase of Endocarditis) Study Group. Effect of early cerebral magnetic resonance imaging on clinical decisions in infective endocarditis: a prospective study. Ann Intern Med. 2010 Apr 20;152(8):497-504, W175. doi: 10.7326/0003-4819-152-8-201004200-00006.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P040431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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