Clinical trial NCT02721472: Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
Official title: Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Theravia
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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.

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.

Primary outcomes:
measure: 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)
timeFrame: 1 days
Secondary outcomes:
measure: Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound
timeFrame: 1 day
measure: Relationship between plasma DNA levels and cardiac damages
timeFrame: 1 day
measure: Relationship between plasma DNA levels and pulmonary blood pressure
timeFrame: 1 day
measure: Relationship between plasma DNA levels and macrocirculatory vascular measurements
timeFrame: 2 days
measure: Relationship between plasma DNA levels and nephropathy
timeFrame: 1 day
measure: Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition
timeFrame: 1 day
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
state: Ile De France
Study officials:
affiliation: Hôpital Avicenne
name: LE JEUNE Sylvain, MD
role: PRINCIPAL_INVESTIGATOR
References: