Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

NCT ID: NCT02721472

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-17
• Study Completion Date: 2019-11-14

Brief Summary

The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

sickle cell disease patients

Sickle cell disease patients included in the study and Plasma DNA levels will be analyzed and compared in patients with a reactive hyperaemia index (RHI) \< 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction).

Group Type: OTHER

micro- and macro-circulatory vascular remodelling measures not practice in routine care

Intervention Type: PROCEDURE

Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity

Biological measures not practice in routine care

Intervention Type: PROCEDURE

Biological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1

Interventions

micro- and macro-circulatory vascular remodelling measures not practice in routine care

Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity

Intervention Type: PROCEDURE

Biological measures not practice in routine care

Biological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Homozygous SS or Sß0 sickle cell disease patients.
• Seen in consultation for an annual clinical and para-clinical evaluation of his/her disease.
• Stable clinical condition of the disease defined as the absence of severe vaso-occlusive crises (requiring hospitalisation or a visit to the emergency unit) in the previous month and absence of transfusion in the previous 3 months.

• Known cardiac arrhythmia.
• Severe Raynaud's syndrome.
• Hand or arm deformity that prevents an EndoPAT analysis.

Exclusion Criteria

• Other haemoglobinopathy
• Known diabetes.
• Recent administration of an anticoagulant treatment at curative doses (< 48h before inclusion), or platelet-inhibiting drugs (less than 1 week prior to inclusion).
• Recent transfusion (less than 3 months prior to inclusion).
• Pregnancy or post-partum (first 40 days after giving birth).
• Recent consumption of alcohol (less than 10h), coffee (less than 3h), and tobacco (less than 36h) before inclusion.
• Known infection with hepatitis B, C, and HIV infection.
• Known cancer or progressive blood disease.
• Known haemostasis or coagulation disorders.
• Progressive inflammatory or infectious diseases.
• Recent history (dating less than 3 months) of venous (pulmonary embolism, deep venous thrombosis) or arterial (acute coronary syndrome, stroke, peripheral arterial ischaemia) thromboembolic event.
• Adult patients subject to legal protection measures.
• Patients already involved in a therapeutic protocol.
• Patients not affiliated to a social security system.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theravia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LE JEUNE Sylvain, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Avicenne

Locations

Hôpital Avicenne

Bobigny, Île-de-France Region, France

Countries

France

Other Identifiers

DRE-FR-15-1

Identifier Type: -

Identifier Source: org_study_id