Stroke Prevention in Young Adults With Sickle Cell Anemia
NCT04808778
Anemia, Anemia, Hemolytic
Nashville, Tennessee, United States
View Trial DetailsNCT Number: NCT05685069
The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk factor assessment as well as noninvasive angiography of the cervical and intracranial arteries will be performed.
Interested in participating?
Request Info16 year and older
All sexes
Observational
Centre Hospitalier Universitaire de Tours, Tours, France
Background: Covert brain infarction (CBI) are incidental lesions of presumably vascular etiology, detected on cerebral imaging and without attributable event of an acute ischemic stroke (AIS). Formerly thought to be completely "silent", CBI do have consequences: patients with CBI have a two-fold increased risk of severe stroke in the future, more often covert neurological deficits, and a steeper decline in cognitive function with increased risk of dementia. Important associations of CBI are described with hypertension, carotid stenosis, chronic kidney disease and metabolic syndrome, heart failure, coronary artery disease, hyperhomocysteinemia and obstructive sleep apnea. No trustworthy guidelines exist how to approach a patient with CBI.
Aim and hypothesis: The investigators want to provide a reliable estimate on the yield and relevance of a complete stroke workup to identify modifiable vascular risk factors in patients with CBI searching for an easily treatable cause of the event like a carotid stenosis, atrial fibrillation, hypertension or diabetes. The investigators' hypothesis is that a complete workup in patients with CBI has a similar yield of underlying pathological findings as compared to workup recommended for AIS.
Design: The SILENT registry is a prospective, interdisciplinary, multimodal observational registry of 230 patients with CBI. Methods: A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography and noninvasive angiography of the cervical and intracranial arteries will be performed.
Statistics: A sample size calculation estimated a sample size of 230 patients. A prespecified analysis protocol will be used.
Significance: This study has the potential to extend the work-up of stroke to patients with CBI. Since CBI are up to three times more frequent than manifest ischemic stroke, this would have huge implications for primary stroke prevention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated:
Time frame: At the end of follow-up (2 years)
Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated:
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
The NIHSS is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities, without coaching and without making assumptions about what the patient can do.
Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity.
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
Unrecognized or unreported stroke-like symptoms, called covert symptoms, e.g. visual field defect or slight ataxia
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA may be administered by anyone who understands and follows the instructions, however, only a health professional with expertise in the cognitive field may interpret the results. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Like the BDI, the BDI-II also contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression.
Time frame: At baseline visit, expected to be at least 3 months after brain imaging
The EQ-5D consists of several components: On the one hand, the self-assessment using the EQ-5D questionnaire, which describes the state of health using five dimensions:
Agility, mobility the ability to take care of yourself Everyday activities (e.g. work, studies, housework, family, free time) pain, physical discomfort fear, depression
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
according to the 2018 ACC/AHA recommendations
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
Elevated HbA1c or random glucose according to the 2017 International Diabetes Federation Guidelines
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
requiring change of management
Time frame: After baseline work-up, expected to be at least 3 months after brain imaging
requiring change of management
Time frame: At the end of follow-up (2 years)
defined as new sudden focal neurological deficit of presumed cerebrovascular etiology, occurring > 24 hours after the index SBI, that persisted beyond 24 hours and was not due to another identifiable cause
Time frame: At the end of follow-up (2 years)
defined as a transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia without cerebral infarction on imaging
Time frame: At the end of follow-up (2 years)
defined as typical symptoms and cardiac biomarker elevation (troponin I or T, creatine kinase-MB) above the upper limit of normal, new pathological Q waves in at least 2 contiguous electrocardiogram leads, or confirmation at autopsy or by coronary angiography or by MRI.
Time frame: At the end of follow-up (2 years)
including subdural, epidural, subarachnoidal and intracerebral hemorrhage, defined as hemorrhage that leads to a clinical worsening and hospitalisation and is assessed by the treating physician to be likely the cause of the new neurological symptom or the death. Intracerebral hemorrhage due to a trauma will not be considered.
Time frame: At the end of follow-up (2 years)
defined as composite of stroke, myocardial infarct, heart failure or cardiovascular death)
Time frame: At the end of follow-up (2 years)
defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion of an extremity or organ in absence of another likely mechanism (e.g. atherosclerosis, instrumentation or trauma)
Time frame: At the end of follow-up (2 years)
defined as death that is due to a vascular cause
Time frame: At the end of follow-up (2 years)
defined as death of any cause
Contact information is provided by the study sponsor or research team.
Thomas Meinel, Dr. med.
CONTACT
Urs Fischer, Prof. Dr. med.
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)
Acronym: CBI-Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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