The Recurrence Study

NCT03244215 | Unknown

• 1 other identifier: 15304/15
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Transient Ischemic Attack

Keywords

Recurrence of stroke; Corneal Confocal Microscopy; High performance liquid chromatography,; Inflammatory biomarkers; modified Rankin scale ( mRS)

Outcome Measures

Primary Outcomes (3)

• Circulating Biomarkers

  The primary outcome will be to assess blood inflammatory biomarker levels in both the study group as well as the controls at baseline

  Blood samples will be assessed at baseline

• Circulating biomarkers

  To assess blood inflammatory biomarker levels in the study group at less than 48 hours

  Blood samples will be extracted at 48 hours

• Circulating biomarkers

  To assess blood inflammatory biomarker levels in the study group at less than 1 month+/- 7 days

  Blood samples will be extracted at 1 month+/- 7 days

Secondary Outcomes (1)

• Progression of disease

  1 year

Study Arms (2)

The study group

EXPERIMENTAL

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; Diagnostic Test: Magnetic resonance Imaging; Other: Blood sample

Control

OTHER

The control group will have blood work done to assess their blood inflammatory biomarkers but not the corneal confocal imaging.

Other: Blood sample

Interventions

Corneal Confocal Imaging DIAGNOSTIC_TEST

Retinal imaging will be ordered for all subjects in the study group. Corneal

The study group

Magnetic resonance Imaging DIAGNOSTIC_TEST

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.

The study group

Blood sample OTHER

Blood samples will be obtained to evaluate the levels of blood inflammatory biomarkers in both the subjects and control group.

Control; The study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

The Neuroscience Institute, Hamad Medical Corporation

Doha, 3500, Qatar

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Magnetic Resonance Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Naveed Akhtar, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

• Ashfaq Shuaib, FRCPC

  University of Alberta

  STUDY CHAIR

Central Study Contacts

Naveed Akhtar, MD

CONTACT

+974 44392773; nakhtar@hamad.qa

Rabia Khan, BSc

CONTACT

+97440253348; rkhan5@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: August 9, 2017
• Study Start: February 17, 2016
• Primary Completion: February 17, 2018
• Study Completion: May 17, 2018
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)