Acute StrokeNETsNCT02476188
Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke
A study testing Sample of Blood in people with Acute Stroke, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Sample of Blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ("Patients" + "Patients control" groups) :
- Inclusion-1st sample of blood : every patient recruited within the neurovascular unit of intensive care of the Hospital center Sainte - Anne within the framework of a "thrombolyse alert ".
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Neutrophil extracellular traps (NETs) were measured in serum at the time of hospitalization, then at 4 hours, 24 hours and 72 hours after stroke. Because of nucleosome instability, a strict preanalytical protocol was followed. Blood samples were centrifuged within 1-2 h after blood drawing. A strict preanalytical protocol was followed including early centrifugation of the samples and storage at - 80°C. NETs were quantified in batches containing all samples from a patient using the detection of MPO (myeloperoxidase) then the Cell-Death-Detection ELISAPLUS (Roche Diagnostics, Germany) as described earlier. Nucleosomes were quantified in relative arbitrary units (AU). Blood samples from each patient were measured within the same run to improve the comparability of the results.
For statistical analysis, various variables of nucleosomes were considered, such as the absolute concentrations determined at admission, at 24 hours and at 72 hours after stroke. Influence of nucleosome concentration on recanalization was tested. Continuous correlations of nucleosomes and infarction volume, nucleosomes and clot size, as well as of infarction volume and NIHSS were calculated by Spearman's rank correlation together with the 95% confidence interval. A p value < 0.05 was considered statistically significant.
The extent of the morphological damage was determined at time of admission to the hospital and 24 hours after thrombolysis by diffusion-weighted magnetic resonance imaging (MRI). The pretreat¬ment and follow-up DWI lesions was segmented using interactive tools based on DWI signal intensity thresholding within a 3-dimensional mask encompassing the apparent area of bright DWI signal intensity and morphometric filtering. The clot location and length were assessed on the susceptibility vessel sign on T2* as describe earlier.
- Conditions
- Acute Stroke
- Being tested
- Sample of Blood
- Keywords
- Neutrophil extracellular traps, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample of BloodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Samples of blood at H0, H+6, H+24 and H+72 Receives: Procedure: Sample of Blood |
| Patients control | Experimental | Samples of blood at H0 Receives: Procedure: Sample of Blood |
| Control (healthy person) | Active comparator | Samples of blood at H0 Receives: Procedure: Sample of Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recanalisation
Correlation between NETs and stroke severity
Measured: 24 hours
Secondary outcomes (2)
Thrombus size on MRI
Correlation between NETs and stroke severity
Measured: 24 hours
Stroke volume on MRI
Correlation between NETs and stroke severity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start31 Jul 2015
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Michel PLOTKINE, PhD, Study director, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476188
- Sponsor's protocol ID
- D15-P007
- Acronym
- NETs
- Status last verified
- Oct 2017
- First submitted
- 11 Jun 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11522104Holdenrieder 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.
PubMed 16040855Naggara 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.
PubMed 24146915
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke
- ClinicalTrials.gov ID
- NCT02476188
- Acronym / sponsor ID
- NETs / D15-P007
- Conditions
- Acute Stroke
- Keywords
- Neutrophil extracellular traps, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neutrophil extracellular traps (NETs) were measured in serum at the time of hospitalization, then at 4 hours, 24 hours and 72 hours after stroke. Because of nucleosome instability, a strict preanalytical protocol was followed. Blood samples were centrifuged within 1-2 h after blood drawing. A strict preanalytical protocol was followed including early centrifugation of the samples and storage at - 80°C. NETs were quantified in batches containing all samples from a patient using the detection of MPO (myeloperoxidase) then the Cell-Death-Detection ELISAPLUS (Roche Diagnostics, Germany) as described earlier. Nucleosomes were quantified in relative arbitrary units (AU). Blood samples from each patient were measured within the same run to improve the comparability of the results.
For statistical analysis, various variables of nucleosomes were considered, such as the absolute concentrations determined at admission, at 24 hours and at 72 hours after stroke. Influence of nucleosome concentration on recanalization was tested. Continuous correlations of nucleosomes and infarction volume, nucleosomes and clot size, as well as of infarction volume and NIHSS were calculated by Spearman's rank correlation together with the 95% confidence interval. A p value < 0.05 was considered statistically significant.
The extent of the morphological damage was determined at time of admission to the hospital and 24 hours after thrombolysis by diffusion-weighted magnetic resonance imaging (MRI). The pretreat¬ment and follow-up DWI lesions was segmented using interactive tools based on DWI signal intensity thresholding within a 3-dimensional mask encompassing the apparent area of bright DWI signal intensity and morphometric filtering. The clot location and length were assessed on the susceptibility vessel sign on T2* as describe earlier.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Sample of BloodSamples of blood at H0, H+6, H+24 and H+72 |
| Patients control | Experimental | Procedure: Sample of BloodSamples of blood at H0 |
| Control (healthy person) | Active comparator | Procedure: Sample of BloodSamples of blood at H0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ("Patients" + "Patients control" groups) :
- Inclusion-1st sample of blood : every patient recruited within the neurovascular unit of intensive care of the Hospital center Sainte - Anne within the framework of a "thrombolyse alert ".
- Age 18 minimum
- Sylvien Infarct proved by the intellectual MRI,
- Whatever is the treatment received (Aspegic, thombolysis and/or thrombectomy)
Key exclusion criteria (4 listed)
- Patients:
- Contraindications in the intravenous thrombolysis according to the current recommendations .
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample of Blood | Procedure or surgery | Control (healthy person), Patients, Patients control |
Primary outcome
Rate of recanalisation
Time frame: 24 hours
Correlation between NETs and stroke severity
2 secondary outcomes
Thrombus size on MRI
Time frame: 24 hours
Stroke volume on MRI
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Background: PubMed 11522104Holdenrieder 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.
- Background: PubMed 16040855Holdenrieder 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.
- Background: PubMed 24146915Naggara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel PLOTKINE, PhD study director
University of Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample of Blood in people with Acute Stroke, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recanalisation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.