Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— PADRE  

Official title:

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721472
• Other study ID #: DRE-FR-15-1
• Status: Completed
• Phase: N/A
• Start date: May 17, 2016
• Est. completion date: November 14, 2019

Study information

• Verified date: January 2020
• Source: ADDMEDICA SASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vascular Remodeling

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
ADDMEDICA SASA

Country where clinical trial is conducted

France, 

Outcome

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