Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies (GADO-ICH)

January 13, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient refusing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with acute lobar and deep haematoma
None, pure observational study
Other: None, pure observational study
None, pure observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of spot sign on gadolinium MRI
Time Frame: baseline
Presence of spot sign on gadolinium MRI (Yes/No)
baseline
Morphologic description of gadolinium MRI spot sign
Time Frame: baseline
morphological (shape, location within the hematoma) description of spot signs on brain MRI
baseline
Quantitative description of gadolinium MRI spot sign
Time Frame: baseline
Quantitative (number and categorial) description of spot signs on brain MRI
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association of spot sign with hematoma expansion on follow-up CT
Time Frame: Baseline
association of spot sign with hematoma expansion on follow-up CT(Yes/No)
Baseline
Association with the underlaying pathology
Time Frame: Baseline
Association with the underlaying pathology as identified by the authors (Yes/No)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2024/TP-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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