Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Disease

• 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

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