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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721472
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
ADDMEDICA SASA

Study Description
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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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care Procedure: Biological measures not practice in routine care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : November 14, 2019
Actual Study Completion Date : November 14, 2019

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Arms and Interventions
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Arm Intervention/treatment
sickle cell disease patients
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).
 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

Procedure: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 1 days ]

Secondary Outcome Measures :
  1. Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound [ Time Frame: 1 day ]
  2. Relationship between plasma DNA levels and cardiac damages [ Time Frame: 1 day ]
  3. Relationship between plasma DNA levels and pulmonary blood pressure [ Time Frame: 1 day ]
  4. Relationship between plasma DNA levels and macrocirculatory vascular measurements [ Time Frame: 2 days ]
  5. Relationship between plasma DNA levels and nephropathy [ Time Frame: 1 day ]
  6. Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721472


Locations
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France
Hôpital Avicenne
Bobigny, Ile De France, France, 93009
Sponsors and Collaborators
ADDMEDICA SASA
Investigators
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Principal Investigator: LE JEUNE Sylvain, MD Hôpital Avicenne
More Information
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Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT02721472    
Other Study ID Numbers: DRE-FR-15-1
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Vascular Remodeling
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathological Conditions, Anatomical
Pathologic Processes