D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Cerebral Infarction Clinical Trial

— D-Dimer  

Official title:

D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938479
• Other study ID #: PI2020_843_0159
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Audrey ARNOUX-COURSELLE, MD
• Phone: 0322668000
• Email: arnoux.audrey[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Biological:
• blood sample
D-dimer measurement in blood sample

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between D-dimer concentration and NIHSS score	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
Primary	Correlation between D-dimer concentration and NIHSS score	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
Primary	Correlation between D-dimer concentration and the Rankin score	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
Primary	Correlation between D-dimer concentration and the Rankin score	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