Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care; Procedure: Biological measures not practice in routine care

• Registration Number: NCT02721472
• Lead Sponsor: Theravia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-29
• Study Start: 2016-05-17
• Primary Completion: 2019-11-14
• Study Completion: 2019-11-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sickle cell disease patients	micro- and macro-circulatory vascular remodelling measures not practice in routine care	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).
sickle cell disease patients	Biological measures not practice in routine care	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).

Primary Outcome Measures

Name	Time	Method
Comparison of plasma DNA levels 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)	1 days

Secondary Outcome Measures

Name	Time	Method
Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound	1 day
Relationship between plasma DNA levels and cardiac damages	1 day
Relationship between plasma DNA levels and pulmonary blood pressure	1 day
Relationship between plasma DNA levels and macrocirculatory vascular measurements	2 days
Relationship between plasma DNA levels and nephropathy	1 day
Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition	1 day

Trial Locations

Locations (1)

Hôpital Avicenne; 🇫🇷 Bobigny, Ile De France, France