NCT04938479

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

June 17, 2021

Last Update Submit

May 9, 2023

Conditions

Keywords

Cerebral Infarctioncerebral infarction recovery

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Interventions

blood sampleBIOLOGICAL

D-dimer measurement in blood sample

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients under 65 years of age who have presented a heart attack brain and undergoing a revascularization procedure

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

D-Dimer measurement in blood sample

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Audrey ARNOUX-COURSELLE, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 24, 2021

Study Start

June 15, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations