Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03376893
Other study ID # 161434
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2, 2017
Est. completion date December 31, 2026

Study information

Verified date August 2023
Source Vanderbilt University Medical Center
Contact Samantha Davis, Masters
Phone +1 (615) 875-7956
Email samantha.davis.1@vumc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with silent strokes and ~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults.


Description:

In three adult SCD centers, we will conduct a prospective cohort study to test the primary hypothesis that the incidence of infarct recurrence (stroke or silent stroke) or new strokes in adults with silent strokes treated with hydroxyurea will be greater than in those without strokes treated with hydroxyurea. We will test two secondary hypotheses: 1) adults with SCD and silent strokes have cognitive morbidity when compared to adults with SCD without silent strokes, and 2) adults with SCD and strokes receiving regular blood transfusion will have a higher incidence of infarct recurrence than those with SCD without strokes. The aims include Aim 1: Compare the incidence of new overt and silent strokes in adults with SCD and silent strokes to a comparison group of adults without silent strokes or overt strokes. Aim 2: Compare the cognitive morbidity of those with silent strokes and overt strokes to those without strokes. Aim 3: Compare the incidence of new overt and silent stroke in adults with SCD and overt strokes receiving transfusion to adults with SCD without silent or overt strokes treated with hydroxyurea. All clinical information and neuroimaging will be centrally adjudicated with masked and experienced neurology and neuroradiology committees. Data generated after completion of this proposal are critical for developing the first-ever phase III trials for secondary stroke prevention therapies in adults with SCD.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants with sickle cell disease on hemoglobin analysis and/or other confirmatory documentation of phenotype 2. Patients = 18 years of age 3. Patients followed regularly (at least two visits per year) in the hematology clinics 4. Patients who have demonstrated adherence with follow-up visits for = 3 years 5. Patients willing to be followed prospectively for a minimum of 3.5 years and agree to a standard care exit MRI/MRA of the brain, as well as MRI/MRA every 12 to 18 months or participation in VUMC AHA trial with Dr. Jordan as PI. These are adults with SCA aged 18-40 years at study entry, enrolled with any infarct status (none, SCI or overt stroke) and followed prospectively. 6. Willingness to comply with study protocol, routine clinic visits Exclusion criteria: 1. Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice 2. Participants with contraindications to MRI, including individuals with MRI-incompatible foreign metal objects

Study Design


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Vanderbilt University Medical Center Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Vanderbilt University Medical Center University of Alabama at Birmingham, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adjudication of silent stroke in those with reported history of silent stroke and hydroxyurea therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether a silent stroke has occurred. Radiologically, silent stroke will be defined as a FLAIR T2W hyperintensity greater than 3 mm, visible in two planes. Neurologically, a silent stroke has no neurological sequelae. Study enrollment
Primary Adjudication of new strokes in those with history of silent stroke and on hydroxyurea therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether a NEW stroke has occurred since the last exams, and if so, whether it is a silent stroke or overt stroke. Radiologically, silent stroke will be defined as a FLAIR T2W hyperintensity greater than 3 mm, visible in two planes. Neurologically, a silent stroke has no neurological sequelae. Every 12 to 18 months after enrollment
Primary Adjudication of new strokes in those with history of silent stroke and on hydroxyurea therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether a NEW stroke has occurred since the last exams, and if so, whether it is a silent stroke or overt stroke. Radiologically, silent stroke will be defined as a FLAIR T2W hyperintensity greater than 3 mm, visible in two planes. Neurologically, a silent stroke has no neurological sequelae. At study exit (at least 3.5 years after enrollment)
Secondary Cognitive morbidity in those with silent or overt stroke All participants will complete the NIH Toolbox CB. The NIH Toolbox CB allows for the evaluation of several cognitive constructs and yields individual measure scores as well as a composite score. This measure will serve as a baseline for all participants. Study enrollment
Secondary Cognitive morbidity in those with silent or overt stroke Participants will complete the NIH Toolbox CB. The NIH Toolbox CB allows for the evaluation of several cognitive constructs and yields individual measure scores as well as a composite score. Results will be compared to the previous measurement(s) to determine if change has occurred. Every 12 to 18 months after enrollment
Secondary Cognitive morbidity in those with silent or overt stroke Participants will complete the NIH Toolbox CB. The NIH Toolbox CB allows for the evaluation of several cognitive constructs and yields individual measure scores as well as a composite score. Results will be compared to the previous measurement(s) to determine if change has occurred. At study exit (at least 3.5 years after enrollment)
Secondary Adjudication of overt stroke in those with reported history of overt stroke and on transfusion therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether an overt stroke has occurred. Study enrollment
Secondary Adjudication of new strokes in those with history of overt stroke and on transfusion therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether a NEW stroke has occurred since the last exams, and if so, whether it is a silent stroke or overt stroke. Radiologically, silent stroke will be defined as a FLAIR T2W hyperintensity greater than 3 mm, visible in two planes. Neurologically, a silent stroke has no neurological sequelae. Every 12 to 18 months after enrollment
Secondary Adjudication of new strokes in those with history of overt stroke and on transfusion therapy Based on results of an MRI exam and a neurological exam, performed by a physician, the Neuroradiology Committee and the Neurology Committee will come to consensus on whether a NEW stroke has occurred since the last exams, and if so, whether it is a silent stroke or overt stroke. Radiologically, silent stroke will be defined as a FLAIR T2W hyperintensity greater than 3 mm, visible in two planes. Neurologically, a silent stroke has no neurological sequelae. At study exit (at least 3.5 years after enrollment)
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A