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

Sponsor
ADDMEDICA SASA (Industry)
Overall Status
Completed
CT.gov ID
NCT02721472
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
41.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care
  • Procedure: Biological measures not practice in routine care
 N/A

Study Design

Study Type:
Interventional
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 :
Nov 14, 2019
Actual Study Completion Date :
Nov 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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

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) [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 [1 day]

  2. Relationship between plasma DNA levels and cardiac damages [1 day]

  3. Relationship between plasma DNA levels and pulmonary blood pressure [1 day]

  4. Relationship between plasma DNA levels and macrocirculatory vascular measurements [2 days]

  5. Relationship between plasma DNA levels and nephropathy [1 day]

  6. Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hôpital Avicenne Bobigny Ile De France France 93009

Sponsors and Collaborators

  • ADDMEDICA SASA

Investigators

  • Principal Investigator: LE JEUNE Sylvain, MD, Hôpital Avicenne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ADDMEDICA SASA
ClinicalTrials.gov Identifier:
NCT02721472
Other Study ID Numbers:
  • DRE-FR-15-1
First Posted:
Mar 29, 2016
Last Update Posted:
Jan 9, 2020
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms:
Anemia, Sickle Cell
Vascular Remodeling

Study Results

No Results Posted as of Jan 9, 2020