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The Recurrence Study

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ClinicalTrials.gov Identifier: NCT03244215
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Naveed Akhtar, Hamad Medical Corporation

Brief Summary:

The primarily goal of the research is to better understand progression of disease in patients who present with an acute stroke to the Hamad General Hospital (HGH) stroke and Transient Ischemic Attack (TIA) clinic. The investigators are specifically interested in patients who have diabetes and have a stroke.

The patients enrolled into the research will have detailed clinical evaluation and their imaging studies (MRI and Doppler) will be reviewed. After informed consent, subjects will be examined in the stroke Ward /TIA clinic upon recruitment, and later at less than 48 hours of recruitment (blood extraction and urine samples) and for follow up visits at 1 month+/-7 days (clinical evaluation and to extract blood and urine samples), at 3 months (telephonic conversation only) and at 1 year (clinical and repeat MRI brain).

During the initial visit at the ward the investigators will collect serum and plasma for proteomic and metabolomic studies. These will be repeated at less than 48 hours and at 1 month+/-7 days. Investigators will test the effects of risk factors such as diabetes/stroke on the endothelial procoagulant and inflammatory state at onset and evaluate if best medical control leads to improvement in such markers.The repeated studies will determine if better management and presence of certain blood biomarkers can predict or translate to slower progression of disease and correlate it with clinical status.


Condition or disease Intervention/treatment Phase
Acute Stroke Transient Ischemic Attack Diagnostic Test: Corneal Confocal Imaging Diagnostic Test: Magnetic resonance Imaging Other: Blood sample Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation Of Risk Of Recurrence Of Stroke And Vascular Events In Patients Presenting With Acute Stroke And Tia To Hamad General Hospital
Actual Study Start Date : February 17, 2016
Estimated Primary Completion Date : February 17, 2018
Estimated Study Completion Date : May 17, 2018

Arm Intervention/treatment
Experimental: The study group

The intervention to be evaluated is the patient response and compliance to best medical treatment and prevention of recognized stroke risk factors and the recurrence of stroke and TIA in the study group and its relation to the incidence of blood biomarkers.

The Nurse practitioners at the stroke ward will withdraw blood and collect urine samples from all the subjects. All the subjects from the study group will have 2 follow up visits (1 month and at 1 year) at HGH and one telephonic follow up at 3 months. The blood samples will be used to monitor blood inflammatory biomarker levels. At the beginning of the study, all subjects will have an MRI scan to assess plaque volume (this MRI scan will be ordered as part of the standard of care as per the policies applied to all stroke patients). MRI scans will be repeated at one year to assess any progression or regression in the plaque volume of the subjects.

No drugs will be administered to the patients for the purpose of our study.

Diagnostic Test: Corneal Confocal Imaging
Retinal imaging will be ordered for all subjects in the study group. Corneal
Diagnostic Test: Magnetic resonance Imaging
MRI will be ordered for all study subjects at the completion of their participation at year 1. The MRI will assess the the progression or regression of the cerebrovascular health of the study subjects.
Other: Blood sample
Blood samples will be obtained to evaluate the levels of blood inflammatory biomarkers in both the subjects and control group.
Control
The control group will have blood work done to assess their blood inflammatory biomarkers but not the corneal confocal imaging.
Other: Blood sample
Blood samples will be obtained to evaluate the levels of blood inflammatory biomarkers in both the subjects and control group.



Primary Outcome Measures :
  1. Circulating Biomarkers [ Time Frame: Blood samples will be assessed at baseline ]
    The primary outcome will be to assess blood inflammatory biomarker levels in both the study group as well as the controls at baseline

  2. Circulating biomarkers [ Time Frame: Blood samples will be extracted at 48 hours ]
    To assess blood inflammatory biomarker levels in the study group at less than 48 hours

  3. Circulating biomarkers [ Time Frame: Blood samples will be extracted at 1 month+/- 7 days ]
    To assess blood inflammatory biomarker levels in the study group at less than 1 month+/- 7 days


Secondary Outcome Measures :
  1. Progression of disease [ Time Frame: 1 year ]
    We will measure the plaque volume in the stroke patients by conducting an MRI scan at admission to the hospital and later repeating it at year 1. We will also utilize corneal confocal imaging as a surrogate procedure to assess the progression of stroke and other vascular events.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects 18 years and older
  • Subjects willing to give consent and agree to regular follow up visits;
  • Male/Female patients of all nationalities admitted to HGH or seen in the Stroke Ward/ TIA clinics with a confirmed diagnosis of acute stroke and TIA, confirmed on the initial standard of care ordered MRI imaging.
  • Stroke onset is less than 48 hours.

Exclusion Criteria:

  • Pregnant women or individuals with cognitive disabilities.
  • individuals with onset > 48 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244215


Contacts
Contact: Naveed Akhtar, MD +974 44392773 ext 94124 nakhtar@hamad.qa
Contact: Rabia Khan, BSc +97440253348 rkhan5@hamad.qa

Locations
Qatar
The Neuroscience Institute, Hamad Medical Corporation Recruiting
Doha, Qatar, 3500
Contact: Naveed Akhtar, MD       nakhtar@hamad.qa   
Contact: Deborah Morgan, BSc       dmorgan@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: Naveed Akhtar, MD Hamad Medical Corporation
Study Chair: Ashfaq Shuaib, FRCPC University of Alberta

Responsible Party: Dr.Naveed Akhtar, Consultant Neurologist, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03244215     History of Changes
Other Study ID Numbers: 15304/15
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share any IPD with other investigators.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr.Naveed Akhtar, Hamad Medical Corporation:
Recurrence of stroke
Corneal Confocal Microscopy
High performance liquid chromatography,
Inflammatory biomarkers
modified Rankin scale ( mRS)

Additional relevant MeSH terms:
Stroke
Recurrence
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Brain Ischemia