Stroke, AcuteRUSHNCT03245957
HDL Dysfunction During the Acute Stage of Stroke
An observational study of Stroke, Acute, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Ischemic stroke and Haemorrhagic stroke
- How many people
- 112 participants
- Where
- 1 siteReunion
- Study dates
- 20 Oct 2017to Mar 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours
Who may be able to join
- Patients with less than 12 hours stroke clinical signs:
- hemiparesis or hemiplegia
- unilateral sensitivity disorder
- language impairment
- balance disorder
- dizziness, bilateral or monocular vision totally or partially lost
Who cannot join
- Pregnancy
- head trauma since the last 3 months
- stroke since the last 3 months
- myocardial infarction since the last 3 months
- patient disagrees to be enrolled in the study
Trial locations and contacts
1 site in 1 country.
Reunion1 site, 1 recruiting
- Recruiting
Chu Reunion Island
Saint-Pierre, Reunion Island, 97410
COURET DAVID, MD, +262262359000, david.couret@chu-reunion.fr
About this study
The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.
Read the detailed description
MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.
Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.
The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.
Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.
- Conditions
- Stroke, Acute
- Being tested
- Ischemic stroke, Haemorrhagic stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic strokeOther
Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
Haemorrhagic strokeOther
Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke | Patients with ischemic stroke diagnosed by MRI or CT scan Receives: Other: Ischemic stroke | |
| Haemorrhagic stroke | Patients without haemorrhagic stroke diagnosed by MRI or CT scan Receives: Other: Haemorrhagic stroke | |
| Mimick stroke | Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma MPO concentrations
Assessment of plasma MPO concentrations during acute stage of stroke
Measured: Through study completion, an average of 6 hours
Secondary outcomes (1)
HDL-MPO concentrations
Assessment of HDL-MPO concentrations during acute stage of stroke
Measured: Through study completion, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start20 Oct 2017
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David COURET, MD, Principal investigator, Centre Hpospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245957
- Sponsor's protocol ID
- 2016/CHU/06
- Acronym
- RUSH
- Status last verified
- Mar 2019
- First submitted
- 8 Aug 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HDL Dysfunction During the Acute Stage of Stroke
- ClinicalTrials.gov ID
- NCT03245957
- Acronym / sponsor ID
- RUSH / 2016/CHU/06
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 10 Aug 2017 (actual)
- 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 study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.
Detailed description
MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.
Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.
The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.
Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | – | Other: Ischemic strokePatients with ischemic stroke diagnosed by MRI or CT scan |
| Haemorrhagic stroke | – | Other: Haemorrhagic strokePatients without haemorrhagic stroke diagnosed by MRI or CT scan |
| Mimick stroke | – | –Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours
Key inclusion criteria (6 listed)
- hemiparesis or hemiplegia
- unilateral sensitivity disorder
- language impairment
- balance disorder
- dizziness, bilateral or monocular vision totally or partially lost
Key exclusion criteria (5 listed)
- Pregnancy
- head trauma since the last 3 months
- stroke since the last 3 months
- myocardial infarction since the last 3 months
- patient disagrees to be enrolled in the study
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 |
|---|---|---|
| Ischemic strokePatients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan | Other | Ischemic stroke |
| Haemorrhagic strokePatients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan | Other | Haemorrhagic stroke |
Primary outcome
Plasma MPO concentrations
Time frame: Through study completion, an average of 6 hours
Assessment of plasma MPO concentrations during acute stage of stroke
1 secondary outcome
HDL-MPO concentrations
Time frame: Through study completion, an average of 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
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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.
David COURET, MD principal investigator
Centre Hpospitalier Universitaire de La REUNION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. 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 Reunion. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine JUHEL, PHD (+262262359949, christine.juhel@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma MPO concentrations (time frame: Through study completion, an average of 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.