NCT02476188

Brief Summary

The purpose of the study was to investigate the correlation between the nucleosome concentration and the rate of recanalization after thrombolysis. All patients were admitted to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke care. The investigators included all patients treated or not by intravenous thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before admission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

June 11, 2015

Last Update Submit

October 18, 2017

Conditions

Acute Stroke

Keywords

Neutrophil extracellular traps, stroke

Outcome Measures

Primary Outcomes (1)

  • Rate of recanalisation

    Correlation between NETs and stroke severity

    24 hours

Secondary Outcomes (2)

  • Thrombus size on MRI

    24 hours

  • Stroke volume on MRI

    24 hours

Study Arms (3)

Patients

EXPERIMENTAL

Samples of blood at H0, H+6, H+24 and H+72

Procedure: Sample of Blood

Patients control

EXPERIMENTAL

Samples of blood at H0

Procedure: Sample of Blood

Control (healthy person)

ACTIVE COMPARATOR

Samples of blood at H0

Procedure: Sample of Blood

Interventions

Sample of BloodPROCEDURE
Control (healthy person)PatientsPatients control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ("Patients" + "Patients control" groups) :
  • Then pursuit of the study ("patients" group only) if :
  • Age 18 minimum
  • Sylvien Infarct proved by the intellectual MRI,
  • Whatever is the treatment received (Aspegic, thombolysis and/or thrombectomy)
  • That there is occlusion of a cerebral artery or not "Controls" group :
  • Healthy subjects,
  • Mated on the age and the vascular risk factors (tobacco, arterial high blood pressure, diabetes and dyslipidémie)

You may not qualify if:

  • Patients:
  • Contraindications in the intravenous thrombolysis according to the current recommendations .
  • Controls:
  • Histories of evolutionary pathology or thrombo-embolique, taken by treatment whatever it is except contraceptive for the women, the viral or bacterial infection in the month precedents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Related Publications (3)

  • Holdenrieder S, Stieber P, Bodenmuller H, Fertig G, Furst H, Schmeller N, Untch M, Seidel D. Nucleosomes in serum as a marker for cell death. Clin Chem Lab Med. 2001 Jul;39(7):596-605. doi: 10.1515/CCLM.2001.095.

    PMID: 11522104BACKGROUND

  • Holdenrieder S, Stieber P, Chan LY, Geiger S, Kremer A, Nagel D, Lo YM. Cell-free DNA in serum and plasma: comparison of ELISA and quantitative PCR. Clin Chem. 2005 Aug;51(8):1544-6. doi: 10.1373/clinchem.2005.049320. No abstract available.

    PMID: 16040855BACKGROUND

  • Naggara O, Raymond J, Domingo Ayllon M, Al-Shareef F, Touze E, Chenoufi M, Gerber S, Mellerio C, Zuber M, Meder JF, Mas JL, Oppenheim C. T2* "susceptibility vessel sign" demonstrates clot location and length in acute ischemic stroke. PLoS One. 2013 Oct 11;8(10):e76727. doi: 10.1371/journal.pone.0076727. eCollection 2013.

    PMID: 24146915BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michel PLOTKINE, PhD

    University of Paris 5 - Rene Descartes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 19, 2015

Study Start

July 31, 2015

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

FR(1)