Arterial Function Parameters and Transcranial Doppler Velocity in Paediatric Patients With Sickle Cell Disease

NCT05748717 | Recruiting

• 1 other identifier: CREC-MN.88/2020/2021
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell disease; Transcranial Doppler Velocity; Arterial Stiffness; Augmentation Index; Arterial Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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.

  Three measurements will be taken over 10 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

Caribbean Institute for Health Research, The University of the West Indies

Kingston, Saint Andrew Parish, KGN20, Jamaica

RECRUITING

Related Publications (7)

• 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.

  PMID: 38505276 BACKGROUND

• Ranque 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.

  PMID: 27582423 BACKGROUND

• Hulbert 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.

  PMID: 20940417 BACKGROUND

• Belizna 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.

  PMID: 22198986 BACKGROUND

• Lemogoum 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.

  PMID: 15534075 BACKGROUND

• Pikilidou 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.

  PMID: 25991400 BACKGROUND

• Adams 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.

  PMID: 1636180 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Angela E Rankine-Mullings, MB;BS

CONTACT

8768545374; angela.rankinemullings@uwimina.edu.jm

Professor Marvin Reid, PhD

CONTACT

8763812939; marvin.reid@uwimona.edu.jm

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: March 1, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: March 1, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)