EndocarditisICE-COCANCT04387513
Impact of Early Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Retrospective Study
An observational study of Endocarditis and Neurologic Complication, run by Gros, Alexandre, M.D..
Trial summary
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Neurologic Complication
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to 31 Dec 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospitalized patients in intensive care unit. They all have an indication of surgery, but they are not all operated (neurological or others contre-indications).
Who may be able to join
- Left endocarditis
- With indication of cardiac surgery
- Severe endocaditis (SOFA score > or = 3/16)
- With pre operative neurological complications
Who cannot join
- Age < 18
- Right endocarditis without left endocarditis
- No severe endocarditis (SOFA score < 3)
- Ne pre operative neurological complications
- Endocarditis without indication of cardiac surgery
About this study
Official title: Impact of Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Multicentric,Retrospective, Propensity-score Matching Study
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Read more
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
- Mortality at 1 year
Secondary endpoints:
- Analyze the factors associated with neurological degradation
- Evaluate the neurological tolerance of cardiac surgery.
Read the detailed description
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
- Mortality at 1 year
Secondary endpoints:
- Analyze the factors associated with neurological degradation
- Evaluate the neurological tolerance of cardiac surgery.
Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.
- Conditions
- Endocarditis, Neurologic Complication
- Being tested
- Cardiac surgery
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Cardiac surgery, if indicated, delayed or not by neurological complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death from any cause
Measured: at 1 year after the diagnosis of endocarditis
Secondary outcomes (1)
Neurogical tolerance
Modified Rankin score after cardiac surgery, 0 (no symptoms at all) to 6 (death)
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Aug 2010
- Primary completion18 Aug 2010
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gros, Alexandre, M.D.
- Responsible party
- Principal investigator, Dr Alexandre Gros, Gros, Alexandre, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387513
- Sponsor's protocol ID
- AlexandreGros
- Acronym
- ICE-COCA
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All individual data are available in an Excel file.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Multicentric,Retrospective, Propensity-score Matching Study
- ClinicalTrials.gov ID
- NCT04387513
- Acronym / sponsor ID
- ICE-COCA / AlexandreGros
- Conditions
- Endocarditis, Neurologic Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Gros, Alexandre, M.D.
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 18 Aug 2010 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 May 2020 (actual)
- 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.
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
- Mortality at 1 year
Secondary endpoints:
- Analyze the factors associated with neurological degradation
- Evaluate the neurological tolerance of cardiac surgery.
Detailed description
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
- Mortality at 1 year
Secondary endpoints:
- Analyze the factors associated with neurological degradation
- Evaluate the neurological tolerance of cardiac surgery.
Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in intensive care unit. They all have an indication of surgery, but they are not all operated (neurological or others contre-indications).
Key inclusion criteria (4 listed)
- Left endocarditis
- With indication of cardiac surgery
- Severe endocaditis (SOFA score > or = 3/16)
- With pre operative neurological complications
Key exclusion criteria (5 listed)
- Age < 18
- Right endocarditis without left endocarditis
- No severe endocarditis (SOFA score < 3)
- Ne pre operative neurological complications
- Endocarditis without indication of cardiac surgery
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 |
|---|---|---|
| Cardiac surgeryCardiac surgery, if indicated, delayed or not by neurological complications | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: at 1 year after the diagnosis of endocarditis
Death from any cause
1 secondary outcome
Neurogical tolerance
Time frame: At 6 months
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 19 May 2020.
- Individual participant dataSharing planned: Undecided. All individual data are available in an Excel file.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocarditis and Neurologic Complication, run by Gros, Alexandre, M.D..
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 4 inclusion and 5 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: at 1 year after the diagnosis of endocarditis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2020.