Role of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia CNS.

July 7, 2024 updated by: Eman Abdul-Hai

This study aimed to determine the Predictive Value of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia.

Specific aims are:

Demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA in Pediatric Hematology unit at Assiut University Hospital

Detect any abnormality with vasculopathy, arterial occlusion and old SCI. Strokes in children with SCD can be prevented by checking a transcranial Doppler (TCD) ultrasound,MRA and providing blood transfusions to children with abnormal blood flow on the TCD and detect Silent cerebral and cerebrovascular changes in SCD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebro-vascular accident is a destructive complication of sickle cell disease, CVA is a important cause of morbidity and mortality individuals with SCD, which cause motor and neurocognitive complications. The CVA pathophysiology can be described by vasculopathy and obstruction caused by the sickle erythrocytes with narrowing of cerebral vessels of the circle of Willis (middle cerebral artery, anterior cerebral artery, anterior communicating artery, internal carotid artery, posterior cerebral artery, and posterior communicating artery).

Patients with sickle cell disease develop vasculopathy and obstruction at specific sites as distal internal carotid artery (ICA) and the proximal segments of the middle cerebral artery (MCA) and anterior cerebral artery (ACA). This Study have been concerned to identify synchronous risk factors for Cerebro-vascular accident and the presence of increase in cerebral blood flow velocity (CBFV) in arterial parts of the polygon of Willis by transcranial doppler (TCD) has been confirmed as the important risk factor for the development of ischemic Cerebrovascular accidents in children and adolescents with SCA. TCD can detect intracranial arterial narrowing caused by arterial vasculopathy associated with SCA. TCD is a non-invasive, portable, and relatively inexpensive method that uses specific areas of the skull to access the intracranial arterial circulation and to measure CBFV in the polygon of Willis arteries, magnetic resonance Angiography (MRA), and cerebral angiography are available for cerebrovascular disease diagnosis.(5-8) However, TCD is due to its operator dependent, it has a narrow application area. Cerebrovascular disease indicates a group of disorders that alter the flow of blood in the brain. The brain's functions can be temporarily or permanently impaired as a result of this change in blood flow. Timely diagnosis and treatment can restore the brain-impaired functions, resulting in a much-improved prognosis for the patients. This review summarizes the basic principles underlying the TCD imaging technique and its utility as a diagnostic tool for cerebrovascular disease.

Study Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eman DR Abdelhai Fathi Soliman, (M.S.C) of pediatric
  • Phone Number: 01028820014
  • Email: eimanabdelhai@gmail.com

Study Contact Backup

  • Name: Khalid PROF. Ibrahim Abdel-Rahman, Professor of pediatrics
  • Phone Number: 01005484357
  • Email: K.elsayh@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders ,at Assiut University pediatric Hospital.

Description

Inclusion Criteria:

  • (1) age, from 24 months to 18 years; (2) hemoglobinopathy diagnosis of Hb SS; (3) the desire and ability to be screened as evidenced by signed parental informed consent and child's assent; (4) the availability for follow-up for at least 2 years.

Exclusion Criteria:

- 1.Other sickle cell syndromes were excluded because they had a lower or uncertain risk of stroke.

2.A child was excluded from TCD screening for any of the following: an indication for chronic blood transfusion or a contraindication to chronic transfusion, participation in any study involving treatments which might confound the interpretation of the results of the proposed work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
This prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders.
Device: transcranial doppler
Demographic and procedural variables will be extracted from medical record assistants , and analysis of recorded images TCD, MRA ,interpretation reports will be assessed , Completeness of protocol components will be assessed Data accuracy and protocol fidelity will be ensured through site monitoring
Other Names:
  • MRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
silent parenchymal and vascular brain changes in Sickle cell disease.
Time Frame: TWO YEARS
the main outcome variable which is to demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA
TWO YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eman Abdul-Hai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 7, 2024

First Submitted That Met QC Criteria

July 7, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sickle cell anemia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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