Subarachnoid HemorrhageHSA-2NCT01218191
Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage.
An observational study of Subarachnoid Hemorrhage, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Feb 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting a SAH
Who may be able to join
- age
- SAH
- Hospitalization in the Military Teaching Hospital Sainte Anne
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive Care Unit, Military Teaching Hospital sainte Anne
Toulon, 83041
About this study
Official title: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH.
The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.
Read the detailed description
The cardiac metabolic disturbance are assessed by a 18F-FDG PET/CT in the first week after SAH and monthly until normal result.
The myocardial sympathetic innervation is assessed by a cardiac 123I-MIBG scintigraphy in the first week after SAH and six months later.
Clinical outcome is assessed by Glasgow Outcome Scale, modified Rankin Scale and MOS-SF36 at 1, 3 and 6 months after SAH.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, scintigraphy, neurocardiogenic injury
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid hemorrhage | Patients presenting a SAH |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac 18F-FDG PET
Measured: first week after SAH
Secondary outcomes (3)
cardiac 123I-MIBG scintigraphy
Measured: first week after SAH
cardiac 18F-FDG PET
Measured: one month after first cardiac 18F-FDG PET
cardiac 123I-MIBG scintigraphy
Measured: Six months after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRUNET Bertrand, Direction Centrale du Service de Santé des Armées
- Investigators
- Eric MEAUDRE, Professor, Study director, Sainte-Anne Military Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218191
- Sponsor's protocol ID
- HSA-2
- Acronym
- HSA-2
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2010
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banki NM, Kopelnik A, Dae MW, Miss J, Tung P, Lawton MT, Drew BJ, Foster E, Smith W, Parmley WW, Zaroff JG. Acute neurocardiogenic injury after subarachnoid hemorrhage. Circulation. 2005 Nov 22;112(21):3314-9. doi: 10.1161/CIRCULATIONAHA.105.558239. Epub 2005 Nov 14.
PubMed 16286583Meaudre E, Jego C, Kenane N, Montcriol A, Boret H, Goutorbe P, Habib G, Palmier B. B-type natriuretic peptide release and left ventricular filling pressure assessed by echocardiographic study after subarachnoid hemorrhage: a prospective study in non-cardiac patients. Crit Care. 2009;13(3):R76. doi: 10.1186/cc7891. Epub 2009 May 20.
PubMed 19454040Prunet B, Basely M, D'Aranda E, Cambefort P, Pons F, Cimarelli S, Dagain A, Desse N, Veyrieres JB, Jego C, Lacroix G, Esnault P, Boret H, Goutorbe P, Bussy E, Habib G, Meaudre E. Impairment of cardiac metabolism and sympathetic innervation after aneurysmal subarachnoid hemorrhage: a nuclear medicine imaging study. Crit Care. 2014 Jun 25;18(3):R131. doi: 10.1186/cc13943.
PubMed 24964817
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT01218191
- Acronym / sponsor ID
- HSA-2 / HSA-2
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, scintigraphy, neurocardiogenic injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Oct 2010 (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.
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH.
The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.
Detailed description
The cardiac metabolic disturbance are assessed by a 18F-FDG PET/CT in the first week after SAH and monthly until normal result.
The myocardial sympathetic innervation is assessed by a cardiac 123I-MIBG scintigraphy in the first week after SAH and six months later.
Clinical outcome is assessed by Glasgow Outcome Scale, modified Rankin Scale and MOS-SF36 at 1, 3 and 6 months after SAH.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid hemorrhage | – | –Patients presenting a SAH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting a SAH
Key inclusion criteria (3 listed)
- age
- SAH
- Hospitalization in the Military Teaching Hospital Sainte Anne
Key exclusion criteria (1 listed)
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac 18F-FDG PET
Time frame: first week after SAH
3 secondary outcomes
cardiac 123I-MIBG scintigraphy
Time frame: first week after SAH
cardiac 18F-FDG PET
Time frame: one month after first cardiac 18F-FDG PET
cardiac 123I-MIBG scintigraphy
Time frame: Six months after SAH
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 20 Feb 2012.
- Background: PubMed 16286583Banki NM, Kopelnik A, Dae MW, Miss J, Tung P, Lawton MT, Drew BJ, Foster E, Smith W, Parmley WW, Zaroff JG. Acute neurocardiogenic injury after subarachnoid hemorrhage. Circulation. 2005 Nov 22;112(21):3314-9. doi: 10.1161/CIRCULATIONAHA.105.558239. Epub 2005 Nov 14.
- Results publication: PubMed 19454040Meaudre E, Jego C, Kenane N, Montcriol A, Boret H, Goutorbe P, Habib G, Palmier B. B-type natriuretic peptide release and left ventricular filling pressure assessed by echocardiographic study after subarachnoid hemorrhage: a prospective study in non-cardiac patients. Crit Care. 2009;13(3):R76. doi: 10.1186/cc7891. Epub 2009 May 20.
- Derived from this study: PubMed 24964817Prunet B, Basely M, D'Aranda E, Cambefort P, Pons F, Cimarelli S, Dagain A, Desse N, Veyrieres JB, Jego C, Lacroix G, Esnault P, Boret H, Goutorbe P, Bussy E, Habib G, Meaudre E. Impairment of cardiac metabolism and sympathetic innervation after aneurysmal subarachnoid hemorrhage: a nuclear medicine imaging study. Crit Care. 2014 Jun 25;18(3):R131. doi: 10.1186/cc13943.
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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.
Eric MEAUDRE, Professor study director
Sainte-Anne Military Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by Direction Centrale du Service de Santé des Armées 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 3 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 20 Feb 2012. 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?
cardiac 18F-FDG PET (time frame: first week after SAH). 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 NCT01218191, which also lists 3 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 20 Feb 2012.