Back to results

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

Primary Purpose

Sickle Cell Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

micro- and macro-circulatory vascular remodelling measures not practice in routine care

Biological measures not practice in routine care

About this trial

This is an interventional diagnostic trial for Sickle Cell Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Avicenne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

sickle cell disease patients

Arm Description

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound

Relationship between plasma DNA levels and cardiac damages

Relationship between plasma DNA levels and pulmonary blood pressure

Relationship between plasma DNA levels and macrocirculatory vascular measurements

Relationship between plasma DNA levels and nephropathy

Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition

Full Information

NCT ID

NCT02721472

First Posted

March 18, 2016

Last Updated

January 7, 2020

Sponsor

ADDMEDICA SASA

1. Study Identification

Unique Protocol Identification Number

NCT02721472

Brief Title

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Acronym

PADRE

Official Title

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 17, 2016 (Actual)

Primary Completion Date

November 14, 2019 (Actual)

Study Completion Date

November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ADDMEDICA SASA

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sickle cell disease patients

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

micro- and macro-circulatory vascular remodelling measures not practice in routine care

Intervention Description

Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity

Intervention Type

Procedure

Intervention Name(s)

Biological measures not practice in routine care

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

1 days

Secondary Outcome Measure Information:

Title

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

Title

Relationship between plasma DNA levels and cardiac damages

Time Frame

1 day

Title

Relationship between plasma DNA levels and pulmonary blood pressure

Time Frame

1 day

Title

Relationship between plasma DNA levels and macrocirculatory vascular measurements

Time Frame

2 days

Title

Relationship between plasma DNA levels and nephropathy

Time Frame

1 day

Title

Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LE JEUNE Sylvain, MD

Organizational Affiliation

Hôpital Avicenne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Avicenne

City

Bobigny

State/Province

Ile De France

ZIP/Postal Code

93009

Country

France

12. IPD Sharing Statement

Learn more about this trial

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

We'll reach out to this number within 24 hrs