Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease (PADRE)

addmedica

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Procedure: Biological measures not practice in routine care; Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02721472

DRE-FR-15-1

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

• Non-inclusion criteria related to the technical requirements of the Endo-PAT:

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

sickle cell disease patients

Other group

Description:

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).

Treatment:

Procedure: Biological measures not practice in routine care

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