HDL Dysfunction During the Acute Stage of Stroke (RUSH)

March 6, 2019 updated by: Centre Hospitalier Universitaire de la Réunion
The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Réunion
    • Reunion Island
      • Saint-Pierre, Reunion Island, Réunion, 97410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ischemic stroke
Patients with ischemic stroke diagnosed by MRI or CT scan
Other: Ischemic stroke
Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
Haemorrhagic stroke
Patients without haemorrhagic stroke diagnosed by MRI or CT scan
Other: Haemorrhagic stroke
Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
Mimick stroke
Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma MPO concentrations
Time Frame: Through study completion, an average of 6 hours
Assessment of plasma MPO concentrations during acute stage of stroke
Through study completion, an average of 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL-MPO concentrations
Time Frame: Through study completion, an average of 6 hours
Assessment of HDL-MPO concentrations during acute stage of stroke
Through study completion, an average of 6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL dysfunction
Time Frame: Through study completion, an average of 6 hours
Assessment of HDL function using inhibition test on cell culture
Through study completion, an average of 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: David COURET, MD, Centre Hpospitalier Universitaire de La REUNION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/CHU/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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