D-Dimer: D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04938479

Collaborator

(none)

Enrollment

Location

9.5

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction Cerebral Infarction Recovery	Biological: blood sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

Correlation between D-dimer concentration and NIHSS score [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.
Correlation between D-dimer concentration and NIHSS score [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.
Correlation between D-dimer concentration and the Rankin score [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.
Correlation between D-dimer concentration and the Rankin score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Patients having benefited from a D-dimer assay (during their stay)

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04938479

Other Study ID Numbers:

PI2020_843_0159

First Posted:

Jun 24, 2021

Last Update Posted:

Jun 28, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Cerebral Infarction

cerebral infarction recovery

Additional relevant MeSH terms:

Cerebral Infarction

Infarction

Study Results

No Results Posted as of Jun 28, 2021