NCT06781034

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 13, 2025

Last Update Submit

January 13, 2025

Conditions

Keywords

Cerebral haemorrhageMRI

Outcome Measures

Primary Outcomes (3)

  • Presence of spot sign on gadolinium MRI

    Presence of spot sign on gadolinium MRI (Yes/No)

    baseline

  • Morphologic description of gadolinium MRI spot sign

    morphological (shape, location within the hematoma) description of spot signs on brain MRI

    baseline

  • Quantitative description of gadolinium MRI spot sign

    Quantitative (number and categorial) description of spot signs on brain MRI

    baseline

Secondary Outcomes (2)

  • association of spot sign with hematoma expansion on follow-up CT

    Baseline

  • Association with the underlaying pathology

    Baseline

Study Arms (1)

patients with acute lobar and deep haematoma

None, pure observational study

Other: None, pure observational study

Interventions

None, pure observational study

patients with acute lobar and deep haematoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share