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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

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE March 29, 2016
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE May 17, 2016
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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 ]
  • Relationship between plasma DNA levels and cardiac damages [ Time Frame: 1 day ]
  • Relationship between plasma DNA levels and pulmonary blood pressure [ Time Frame: 1 day ]
  • Relationship between plasma DNA levels and macrocirculatory vascular measurements [ Time Frame: 2 days ]
  • Relationship between plasma DNA levels and nephropathy [ Time Frame: 1 day ]
  • Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
Official Title  ICMJE Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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).
Interventions:
  • Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care
  • Procedure: Biological measures not practice in routine care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2020)		 44
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)		 45
Actual Study Completion Date  ICMJE November 14, 2019
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02721472
Other Study ID Numbers  ICMJE DRE-FR-15-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ADDMEDICA SASA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ADDMEDICA SASA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LE JEUNE Sylvain, MD Hôpital Avicenne
PRS Account ADDMEDICA SASA
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP