Cerebral HemorrhageGADO-ICHNCT06781034
Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies
An observational study of Cerebral Hemorrhage and Acute Lobar Haematoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage, Acute Lobar Haematoma
- What is being tested?
- None, pure observational study
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with acute cerebral hematoma from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy; who underwent a follow-up cerebral CT scan in the event of worsening or for follow-up.
Who may be able to join
- Patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at Nîmes University Hospital;
- Patients who have undergone a follow-up cerebral CT scan in the event of worsening or for follow-up.
Who cannot join
- Patient refusing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes, Gard, 30029
Anissa MEGZARI, + 33 4.66.68.30.09, drc@chu-nimes.fr
Teodora PARVU, MD
About this study
Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment.
Arterial contrast ("spot sign") within the hematoma has been described in CT scans as a risk factor for further enlargement and poor prognosis.
Read more
An equivalent marker has also been described in gadolinium-enhanced MRI.
By studying the radiological appearance of gadolinium "spot signs" on MRI, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.
- Conditions
- Cerebral Hemorrhage, Acute Lobar Haematoma
- Being tested
- None, pure observational study
- Keywords
- Cerebral haemorrhage, MRI
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observational studyOther
None, pure observational study
| Study group | Role | What they receive |
|---|---|---|
| patients with acute lobar and deep haematoma | None, pure observational study Receives: Other: None, pure observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of spot sign on gadolinium MRI
Presence of spot sign on gadolinium MRI (Yes/No)
Measured: baseline
Morphologic description of gadolinium MRI spot sign
morphological (shape, location within the hematoma) description of spot signs on brain MRI
Measured: baseline
Quantitative description of gadolinium MRI spot sign
Quantitative (number and categorial) description of spot signs on brain MRI
Measured: baseline
Secondary outcomes (2)
association of spot sign with hematoma expansion on follow-up CT
association of spot sign with hematoma expansion on follow-up CT(Yes/No)
Measured: Baseline
Association with the underlaying pathology
Association with the underlaying pathology as identified by the authors (Yes/No)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781034
- Sponsor's protocol ID
- Local/2024/TP-02
- Acronym
- GADO-ICH
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies
- ClinicalTrials.gov ID
- NCT06781034
- Acronym / sponsor ID
- GADO-ICH / Local/2024/TP-02
- Conditions
- Cerebral Hemorrhage, Acute Lobar Haematoma
- Keywords
- Cerebral haemorrhage, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jan 2025 (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.
Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment.
Arterial contrast ("spot sign") within the hematoma has been described in CT scans as a risk factor for further enlargement and poor prognosis.
An equivalent marker has also been described in gadolinium-enhanced MRI.
By studying the radiological appearance of gadolinium "spot signs" on MRI, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute lobar and deep haematoma | – | Other: None, pure observational studyNone, pure observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute cerebral hematoma from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy; who underwent a follow-up cerebral CT scan in the event of worsening or for follow-up.
Key inclusion criteria (2 listed)
- Patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at Nîmes University Hospital;
- Patients who have undergone a follow-up cerebral CT scan in the event of worsening or for follow-up.
Key exclusion criteria (1 listed)
- Patient refusing to participate
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 |
|---|---|---|
| None, pure observational studyNone, pure observational study | Other | patients with acute lobar and deep haematoma |
Primary outcome
Presence of spot sign on gadolinium MRI
Time frame: baseline
Presence of spot sign on gadolinium MRI (Yes/No)
Morphologic description of gadolinium MRI spot sign
Time frame: baseline
morphological (shape, location within the hematoma) description of spot signs on brain MRI
Quantitative description of gadolinium MRI spot sign
Time frame: baseline
Quantitative (number and categorial) description of spot signs on brain MRI
2 secondary outcomes
association of spot sign with hematoma expansion on follow-up CT
Time frame: Baseline
Association with the underlaying pathology
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
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 Cerebral Hemorrhage and Acute Lobar Haematoma, run by Centre Hospitalier Universitaire de Nīmes 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 2 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teodora PARVU (04.66.68.32.61, teodora.parvu@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of spot sign on gadolinium MRI (time frame: baseline). The study lists 3 primary outcomes in all. 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 1 Jul 2026.