Sickle Cell DiseaseAFATNCT05748717
Arterial Function Parameters and Transcranial Doppler Velocity in Paediatric Patients With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Structural and functional changes in arteries are increasingly being recognized as significant features of sickle cell disease. This study aims to determine whether there are differences in arterial function parameters between children with sickle cell disease with normal and abnormal transcranial Doppler velocity. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 34 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Feb 2023to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric participants with sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab) Age 4-16 years with or without a previous stroke with at least one previous transcranial Doppler study.
Who may be able to join
- Pediatric participants with sickle cell anaemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab)
- Age: Between 4-16 years of age, at the time of enrolment
- Has had at least one complete TCD study whether or not on hydroxyurea treatment or in a clinical trial.
- Parent or guardian willing and able to provide informed consent and child gives assent
- Ability to comply with study-related evaluations.
Who cannot join
- Participants who meet any of the following criteria are disqualified from enrollment in the study:
- Patients in whom a TCD study cannot be completed
- Patients who have had an Erythrocyte transfusion in the past two months
- Patients who are acutely ill or have had an acute infection in the past two weeks
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
Caribbean Institute for Health Research, The University of the West Indies
Kingston, Saint Andrew Parish, KGN20
Angela E Rankine-Mullings, MB;BS, 8768545374, angela.rankinemullings@uwimona.edu.jm
Marvin Reid, PhD, 8763825576, marvin.reid@uwimona.edu.jm
About this study
Official title: The Relationship of Transcranial Doppler Velocity With Other Vascular Measurements in Children With Sickle Cell Anaemia
Structural and functional changes in arteries are increasingly being recognized as significant features of sickle cell disease. This study aims to determine whether there are differences in arterial function parameters between children with sickle cell disease with normal and abnormal transcranial Doppler velocity. After informed consent is obtained, participants will have vascular, Transcranial Doppler, haematological and biochemical parameters measured. Researchers will compare children with sickle cell disease who have normal Transcranial Doppler velocity and no history of stroke with children with those who have an abnormal Transcranial Doppler velocity with or without a history of stroke to see if there are significant differences in arterial function parameters.
Read the detailed description
Structural and functional changes in arteries are increasingly being recognized as significant features of sickle cell disease and arterial function in sickle cell anaemia (SCA) is gaining importance.
The goal of this observational study is to compare arterial parameters in children with sickle cell disease who have normal or abnormal Transcranial Doppler velocity. The main question it aims to answer is: whether there is a significant difference in arterial Function parameters measured by aortic pulse wave velocity, augmentation index, brachial and central blood pressure in Jamaican children with Sickle Cell anaemia who attend the Sickle Cell Unit in Kingston Jamaica who are reported to have normal or an abnormal Transcranial Doppler velocity and whether the probability of having an abnormal Transcranial Doppler velocity or higher arterial function parameters is increased by specific biophysical markers.
Participants who are identified will be informed about the study and potential risks. All patients giving written informed consent will then undergo arterial function (arteriograph,TensioMed® Arteriograph24™,Budapest, H-1181 Hungary), Transcranial Doppler, haematological and biochemical measurements.
Researchers will compare children with sickle cell disease who have normal Transcranial Doppler velocity and no history of stroke with children with this illness who have an abnormal Transcranial Doppler velocity to see if there are significant differences in regional arterial function.
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell disease, Transcranial Doppler Velocity, Arterial Stiffness, Augmentation Index, Arterial Function
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients with sickle cell disease with normal TCD velocity without clinical stroke | Patients in this group will be aged 4 to 16 years with sickle cell anaemia with no prior history of stroke or previous Transcranial Doppler study showing a maximum time-averaged mean velocity of greater than 169 cm/sec, and who have not received a red cell transfusion in the past two months and are considered to be at steady state. | |
| Paediatric patients with sickle cell disease with an abnormal TCD velocity (with or without stroke) | Patients in this group will be aged 4 to 16 years with sickle cell anaemia with an abnormal TCD velocity, who have not received a red cell transfusion in the past two months and are considered to be at steady state. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in aortic pulse wave velocity in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
The primary outcome of aortic pulse wave velocity in mmHg, will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in aortic augmentation index, in % between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke.
The primary outcome of aortic augmentation index, in % will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Secondary outcomes (6)
Mean difference in brachial augmentation index, in %, between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Brachial augmentation index, in %, will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in aortic systolic blood pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Aortic systolic blood pressure in mmHg, will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in aortic pulse pressure, in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Aortic pulse pressure in mmHg, will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in brachial systolic pressure in mmHg, between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Brachial systolic pressure in mmHg will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in brachial diastolic pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke.
Brachial diastolic pressure in mmHg will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes
Difference in mean arterial pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Mean arterial pressure in mmHg will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Measured: Three measurements will be taken over 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marvin E Reid, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748717
- Sponsor's protocol ID
- CREC-MN.88/2020/2021
- Acronym
- AFAT
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palomarez A, Jha M, Medina Romero X, Horton RE. Cardiovascular consequences of sickle cell disease. Biophys Rev (Melville). 2022 Aug 8;3(3):031302. doi: 10.1063/5.0094650. eCollection 2022 Sep.
PubMed 38505276Ranque B, Menet A, Boutouyrie P, Diop IB, Kingue S, Diarra M, N'Guetta R, Diallo D, Diop S, Diagne I, Sanogo I, Tolo A, Chelo D, Wamba G, Gonzalez JP, Abough'elie C, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Faye BF, Seck M, Kouakou B, Kamara I, Le Jeune S, Jouven X. Arterial Stiffness Impairment in Sickle Cell Disease Associated With Chronic Vascular Complications: The Multinational African CADRE Study. Circulation. 2016 Sep 27;134(13):923-33. doi: 10.1161/CIRCULATIONAHA.115.021015. Epub 2016 Aug 31.
PubMed 27582423Hulbert ML, McKinstry RC, Lacey JL, Moran CJ, Panepinto JA, Thompson AA, Sarnaik SA, Woods GM, Casella JF, Inusa B, Howard J, Kirkham FJ, Anie KA, Mullin JE, Ichord R, Noetzel M, Yan Y, Rodeghier M, Debaun MR. Silent cerebral infarcts occur despite regular blood transfusion therapy after first strokes in children with sickle cell disease. Blood. 2011 Jan 20;117(3):772-9. doi: 10.1182/blood-2010-01-261123. Epub 2010 Oct 12.
PubMed 20940417Belizna C, Loufrani L, Ghali A, Lahary A, Primard E, Louvel JP, Henrion D, Levesque H, Ifrah N. Arterial stiffness and stroke in sickle cell disease. Stroke. 2012 Apr;43(4):1129-30. doi: 10.1161/STROKEAHA.111.635383. Epub 2011 Dec 22.
PubMed 22198986Lemogoum D, Van Bortel L, Najem B, Dzudie A, Teutcha C, Madu E, Leeman M, Degaute JP, van de Borne P. Arterial stiffness and wave reflections in patients with sickle cell disease. Hypertension. 2004 Dec;44(6):924-9. doi: 10.1161/01.HYP.0000148506.73622.ba. Epub 2004 Nov 8.
PubMed 15534075Pikilidou M, Yavropoulou M, Antoniou M, Papakonstantinou E, Pantelidou D, Chalkia P, Nilsson P, Yovos J, Zebekakis P. Arterial Stiffness and Peripheral and Central Blood Pressure in Patients With Sickle Cell Disease. J Clin Hypertens (Greenwich). 2015 Sep;17(9):726-31. doi: 10.1111/jch.12572. Epub 2015 May 20.
PubMed 25991400Adams RJ, Nichols FT, Figueroa R, McKie V, Lott T. Transcranial Doppler correlation with cerebral angiography in sickle cell disease. Stroke. 1992 Aug;23(8):1073-7. doi: 10.1161/01.str.23.8.1073.
PubMed 1636180
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Transcranial Doppler Velocity With Other Vascular Measurements in Children With Sickle Cell Anaemia
- ClinicalTrials.gov ID
- NCT05748717
- Acronym / sponsor ID
- AFAT / CREC-MN.88/2020/2021
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell disease, Transcranial Doppler Velocity, Arterial Stiffness, Augmentation Index, Arterial Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Structural and functional changes in arteries are increasingly being recognized as significant features of sickle cell disease. This study aims to determine whether there are differences in arterial function parameters between children with sickle cell disease with normal and abnormal transcranial Doppler velocity. After informed consent is obtained, participants will have vascular, Transcranial Doppler, haematological and biochemical parameters measured. Researchers will compare children with sickle cell disease who have normal Transcranial Doppler velocity and no history of stroke with children with those who have an abnormal Transcranial Doppler velocity with or without a history of stroke to see if there are significant differences in arterial function parameters.
Detailed description
Structural and functional changes in arteries are increasingly being recognized as significant features of sickle cell disease and arterial function in sickle cell anaemia (SCA) is gaining importance.
The goal of this observational study is to compare arterial parameters in children with sickle cell disease who have normal or abnormal Transcranial Doppler velocity. The main question it aims to answer is: whether there is a significant difference in arterial Function parameters measured by aortic pulse wave velocity, augmentation index, brachial and central blood pressure in Jamaican children with Sickle Cell anaemia who attend the Sickle Cell Unit in Kingston Jamaica who are reported to have normal or an abnormal Transcranial Doppler velocity and whether the probability of having an abnormal Transcranial Doppler velocity or higher arterial function parameters is increased by specific biophysical markers.
Participants who are identified will be informed about the study and potential risks. All patients giving written informed consent will then undergo arterial function (arteriograph,TensioMed® Arteriograph24™,Budapest, H-1181 Hungary), Transcranial Doppler, haematological and biochemical measurements.
Researchers will compare children with sickle cell disease who have normal Transcranial Doppler velocity and no history of stroke with children with this illness who have an abnormal Transcranial Doppler velocity to see if there are significant differences in regional arterial function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients with sickle cell disease with normal TCD velocity without clinical stroke | – | –Patients in this group will be aged 4 to 16 years with sickle cell anaemia with no prior history of stroke or previous Transcranial Doppler study showing a maximum time-averaged mean velocity of greater than 169 cm/sec, and who have not received a red cell transfusion in the past two months and are considered to be at steady state. |
| Paediatric patients with sickle cell disease with an abnormal TCD velocity (with or without stroke) | – | –Patients in this group will be aged 4 to 16 years with sickle cell anaemia with an abnormal TCD velocity, who have not received a red cell transfusion in the past two months and are considered to be at steady state. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric participants with sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab) Age 4-16 years with or without a previous stroke with at least one previous transcranial Doppler study.
Key inclusion criteria (5 listed)
- Pediatric participants with sickle cell anaemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab)
- Age: Between 4-16 years of age, at the time of enrolment
- Has had at least one complete TCD study whether or not on hydroxyurea treatment or in a clinical trial.
- Parent or guardian willing and able to provide informed consent and child gives assent
- Ability to comply with study-related evaluations.
Key exclusion criteria (4 listed)
- Participants who meet any of the following criteria are disqualified from enrollment in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean difference in aortic pulse wave velocity in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes at the study visit.
The primary outcome of aortic pulse wave velocity in mmHg, will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
Mean difference in aortic augmentation index, in % between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke.
Time frame: Three measurements will be taken over 10 minutes at the study visit.
The primary outcome of aortic augmentation index, in % will be measured in all patients with an Arteriograph 24 (TensioMed, Budapest, Hungary). Before the assessment, the patient will be allowed to rest for 5 -10 minutes. An appropriate cuff size will be used for each patient. The test will be carried out in a calm, temperature-controlled room.
6 secondary outcomes
Mean difference in brachial augmentation index, in %, between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in aortic systolic blood pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in aortic pulse pressure, in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in brachial systolic pressure in mmHg, between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes at the study visit.
Mean difference in brachial diastolic pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke.
Time frame: Three measurements will be taken over 10 minutes
Difference in mean arterial pressure in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke
Time frame: Three measurements will be taken over 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 38505276Palomarez A, Jha M, Medina Romero X, Horton RE. Cardiovascular consequences of sickle cell disease. Biophys Rev (Melville). 2022 Aug 8;3(3):031302. doi: 10.1063/5.0094650. eCollection 2022 Sep.
- Background: PubMed 27582423Ranque B, Menet A, Boutouyrie P, Diop IB, Kingue S, Diarra M, N'Guetta R, Diallo D, Diop S, Diagne I, Sanogo I, Tolo A, Chelo D, Wamba G, Gonzalez JP, Abough'elie C, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Faye BF, Seck M, Kouakou B, Kamara I, Le Jeune S, Jouven X. Arterial Stiffness Impairment in Sickle Cell Disease Associated With Chronic Vascular Complications: The Multinational African CADRE Study. Circulation. 2016 Sep 27;134(13):923-33. doi: 10.1161/CIRCULATIONAHA.115.021015. Epub 2016 Aug 31.
- Background: PubMed 20940417Hulbert ML, McKinstry RC, Lacey JL, Moran CJ, Panepinto JA, Thompson AA, Sarnaik SA, Woods GM, Casella JF, Inusa B, Howard J, Kirkham FJ, Anie KA, Mullin JE, Ichord R, Noetzel M, Yan Y, Rodeghier M, Debaun MR. Silent cerebral infarcts occur despite regular blood transfusion therapy after first strokes in children with sickle cell disease. Blood. 2011 Jan 20;117(3):772-9. doi: 10.1182/blood-2010-01-261123. Epub 2010 Oct 12.
- Background: PubMed 22198986Belizna C, Loufrani L, Ghali A, Lahary A, Primard E, Louvel JP, Henrion D, Levesque H, Ifrah N. Arterial stiffness and stroke in sickle cell disease. Stroke. 2012 Apr;43(4):1129-30. doi: 10.1161/STROKEAHA.111.635383. Epub 2011 Dec 22.
- Background: PubMed 15534075Lemogoum D, Van Bortel L, Najem B, Dzudie A, Teutcha C, Madu E, Leeman M, Degaute JP, van de Borne P. Arterial stiffness and wave reflections in patients with sickle cell disease. Hypertension. 2004 Dec;44(6):924-9. doi: 10.1161/01.HYP.0000148506.73622.ba. Epub 2004 Nov 8.
- Background: PubMed 25991400Pikilidou M, Yavropoulou M, Antoniou M, Papakonstantinou E, Pantelidou D, Chalkia P, Nilsson P, Yovos J, Zebekakis P. Arterial Stiffness and Peripheral and Central Blood Pressure in Patients With Sickle Cell Disease. J Clin Hypertens (Greenwich). 2015 Sep;17(9):726-31. doi: 10.1111/jch.12572. Epub 2015 May 20.
- Background: PubMed 1636180Adams RJ, Nichols FT, Figueroa R, McKie V, Lott T. Transcranial Doppler correlation with cerebral angiography in sickle cell disease. Stroke. 1992 Aug;23(8):1073-7. doi: 10.1161/01.str.23.8.1073.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela E Rankine-Mullings, MB;BS (8768545374, angela.rankinemullings@uwimina.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in aortic pulse wave velocity in mmHg between patients with an abnormal transcranial Doppler Velocity compared to those with a normal Transcranial Doppler velocity without stroke (time frame: Three measurements will be taken over 10 minutes at the study visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748717, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.