- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04800809
The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria
Stroke Registry for Children and Young Adults With Sickle Cell Disease in Nigeria - The Afolabi Stroke Registry
Study Overview
Status
Conditions
Detailed Description
The study is a multi-center, prospective observational cohort study. Thus, it is designed to be a longitudinal registry of strokes in children and young adults with SCA in Nigeria. Participants will be recruited from multiple sites in Nigeria that agree to participate. This study does not entail offering any intervention; all data collected will be based on standard of care. As new information is obtained about the rate of stroke recurrence, risk factors for strokes, and best treatment for strokes in children and young adults with SCA, the site investigators will share this information with the participants in the registry and their parents.
Children and young adults with SCA will be consented to participate in the Afolabi Stroke Registry after a diagnosis of a stroke has been made within 3 months of the event. To enhance retention, the Investigators developed strategies to reduce loss-to-follow-up, including clear written participant instructions, reimbursing patient transportation costs for follow-up visits outside standard care visits, and fortnightly study phone calls. Further, the Investigators will request the names, addresses, and phone numbers of two family members or friends who know how to reach the participant in the event of a missed appointment (this information will be kept at each site and will not be entered into the central database). A medical history and physical examination, magnetic resonance imaging/magnetic resonance angiography (MRI/MRA), and neurological examination will be completed prior to enrollment of participants to confirm their eligibility for the study. Data on patients' demographics, stroke risk factors, and severity of strokes using the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements or modified Rankin scale at baseline and annually. Children and young adults with SCA will be consented to participate in the Afolabi Stroke Registry after a diagnosis of a stroke has been made within 3 months of the event. To enhance retention, the Investigators developed strategies to reduce loss-to-follow-up, including clear written participant instructions, reimbursing patient transportation costs for follow-up visits outside standard care visits, and fortnightly study phone calls. Further, the Investigators will request the names, addresses, and phone numbers of two family members or friends who know how to reach the participant in the event of a missed appointment (this information will be kept at each site and will not be entered into the central database).A medical history and physical examination, MRI/MRA, and neurological examination will be completed prior to enrollment of participants to confirm their eligibility for the study. Data on patients' demographics, stroke risk factors, and severity of strokes using the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements or modified Rankin scale at baseline and annually.
Each participant will be prospectively followed until at least 10 years. the Investigators will collect and record all acute neurological events (overt stroke and TIA) requiring hospitalization or emergency department visits during the study. Imaging and clinical data collected as part of standard care will be used for secondary analysis. Research information, including consent forms, questionnaires, and results of cognitive testing will be maintained in a secure fashion in research charts in a locked file room or locked file cabinet, or in a secure Research Electronic Data Capture (REDCap) database.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kano, Nigeria
- Aminu Kano Teaching Hospital
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Kano, Nigeria, PMB 3452
- Jamil Galadanci
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Tennessee
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Nashville, Tennessee, United States, 37232-9000
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants with sickle cell disease confirmed with hemoglobin electrophoresis or HPLC
- Age 5 to 26 years old
- Present within three months of stroke event that is diagnosed as a stroke by the local health care provider
- Medical records are available for review for the stroke event that occurred within 3 months
- Prior treatment in the SPIN, SPRING and SPRINT trials for primary or secondary stroke prevention
Exclusion Criteria:
- Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
- Participants with contraindications to MRI, including individuals with MRI- incompatible foreign metal objects
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Children and young adults with SCD and stroke
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This study does not entail offering any intervention; all data collected will be based on standard of care.
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The participants in SPIN and SPRING and SPRINT Trials
The participants enrolled in our previous primary and secondary stroke prevention trials in northern Nigeria; SPIN and SPRING (children with SCD with normal and abnormal TCD measurements; NCT02560935 and NCT01801423), SPRINT (children with SCD and strokes; NCT02675790) Trials for ascertainment of incidences rates of strokes in children and young adults receiving standard care after completion of primary stroke prevention trials.
For this purpose, we will enroll these participants to follow their progress after completion of the trials.
No intervention is planned, only to follow the participants with and without abnormal TCD measurements and with and without strokes.
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This study does not entail offering any intervention; all data collected will be based on standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria.
Time Frame: 10 years
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To determine the incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria.
For this purpose, an electronic online registry will be created.
All children and young adults ages between 5 to 26 years old with SCD who are being followed at the participating sites in Nigeria will be consented to enroll to the Afolabi SCD Stroke Registry in Nigeria.
The Investigators will collect and document all acute neurological events (stroke and transient ischemic attacks (TIA) requiring hospitalization or ED visits during the study.
Imaging and clinical data collected as part of standard care will be used for secondary analysis.
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-SCD and SCD risk factors for stroke in children and young adults with SCD.
Time Frame: 10 years
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To assess non-SCD risk factors in combination with SCD risk factors for stroke in children and young adults (16-25 years of age) with SCD.
For this purpose, all participants will also be screened as per standard care for conventional risk factors of stroke (hypertension, smoking, diabetes, obesity, renal disease, cardiomyopathy, and atrial fibrillation).
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10 years
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The incidence of neurological morbidity and mortality in children and young adults with SCD.
Time Frame: 10 years
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To determine the one year and two to five-year incidence of neurological morbidity and mortality in children and young adults with SCD.
Data gathered from this registry will advance the care of children and young adults with SCD not only in Africa but will fill an information gap to improve the neurological outcomes in other low-resource settings.
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10 years
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Long-term follow-up of the participants in the SPIN, SPRING, and SPRINT Trials
Time Frame: 10 years
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To follow the participants in SPIN and SPRING (those with normal and abnormal TCD measurements; NCT02560935 and NCT01801423) and SPRINT (children with strokes; NCT02675790) long-term for ascertainment of incidences rates of strokes in children and young adults receiving standard care after completion of primary stroke prevention trials.
For this purpose, the Investigators will enroll participants in the primary and secondary stroke trials to follow their progress after completion of the trial.
No intervention is planned, only to follow the participants with and without abnormal transcranial Doppler measurements and with and without strokes.
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10 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael R DeBaun, MD, MPH, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Stroke
- Anemia
- Anemia, Sickle Cell
- Neurologic Manifestations
Other Study ID Numbers
- 191560
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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