- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04938479
D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure (D-Dimer)
Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.
The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 to 65
- Cerebral infarctions undergoing a revascularization procedure by thrombolysis and / or thrombectomy, at the Amiens University Hospital between January 2015 and December 2020.
- Patients having benefited from a D-dimer assay (during their stay)
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between D-dimer concentration and NIHSS score
Time Frame: 3 months
|
NIHSS score is based on the clinical neurological examination of the patient.
Validated by the scientific community of vascular neurology, among other things in projective clinical research.
This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
|
3 months
|
|
Correlation between D-dimer concentration and NIHSS score
Time Frame: 6 months
|
NIHSS score is based on the clinical neurological examination of the patient.
Validated by the scientific community of vascular neurology, among other things in projective clinical research.
This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
|
6 months
|
|
Correlation between D-dimer concentration and the Rankin score
Time Frame: 3 months
|
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke. Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery. |
3 months
|
|
Correlation between D-dimer concentration and the Rankin score
Time Frame: 6 months
|
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke. Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery. |
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Brain Infarction
- Brain Ischemia
- Infarction
- Necrosis
- Ischemia
- Stroke
- Pathological Conditions, Signs and Symptoms
- Cerebral Infarction
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- PI2020_843_0159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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