Endocarditis, BacterialIMAGENCT00144885
IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis
A study testing Modification of therapy in people with Endocarditis, Bacterial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endocarditis, Bacterial
- What is being tested?
- Modification of therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute phase of infective endocarditis
Who cannot join
- Contra indication to RMN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endocarditis, Bacterial
- Being tested
- Modification of therapy
- Keywords
- Endocarditis, RMI, Impact measure
- Medical subject headings
- Endocarditis, Bacterial, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification of therapyBehavioural
Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described Receives: Behavioral: Modification of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of therapeutic project
Measured: As soon as RMI is performed
Secondary outcomes (1)
Modification of diagnostic classification (Duke modified criteria)
Measured: As soon as RMI is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endocarditis, BacterialStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Xavier Duval, Principal investigator, Hôpital Bichat, Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144885
- Sponsor's protocol ID
- P040431
- Acronym
- IMAGE
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24497495Iung 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.
PubMed 24003046Iung 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.
PubMed 22334638Duval 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.
PubMed 20404380
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact
- ClinicalTrials.gov ID
- NCT00144885
- Acronym / sponsor ID
- IMAGE / P040431
- Conditions
- Endocarditis, Bacterial
- Keywords
- Endocarditis, RMI, Impact measure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Behavioral: Modification of therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute phase of infective endocarditis
Key exclusion criteria (1 listed)
- Contra indication to RMN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modification of therapyModification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results | Behavioural | 1 |
Primary outcome
Modification of therapeutic project
Time frame: As soon as RMI is performed
1 secondary outcome
Modification of diagnostic classification (Duke modified criteria)
Time frame: As soon as RMI is performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- Derived from this study: PubMed 24497495Mahr 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.
- Derived from this study: PubMed 24003046Iung 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.
- Derived from this study: PubMed 22334638Iung 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.
- Derived from this study: PubMed 20404380Duval 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Duval principal investigator
Hôpital Bichat, Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modification of therapy in people with Endocarditis, Bacterial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of therapeutic project (time frame: As soon as RMI is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144885, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.