NCT02721472

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

March 18, 2016

Last Update Submit

January 7, 2020

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (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 Outcomes (6)

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

    1 day

  • Relationship between plasma DNA levels and cardiac damages

    1 day

  • Relationship between plasma DNA levels and pulmonary blood pressure

    1 day

  • Relationship between plasma DNA levels and macrocirculatory vascular measurements

    2 days

  • Relationship between plasma DNA levels and nephropathy

    1 day

  • +1 more secondary outcomes

Study Arms (1)

sickle cell disease patients

OTHER

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 careProcedure: Biological measures not practice in routine care

Interventions

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

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

sickle cell disease patients
Biological measures not practice in routine carePROCEDURE

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

sickle cell disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Other haemoglobinopathy
  • Known diabetes.
  • Pregnancy or post-partum (first 40 days after giving birth).
  • 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.
  • Known cardiac arrhythmia.
  • Severe Raynaud's syndrome.
  • Hand or arm deformity that prevents an EndoPAT analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Avicenne

Bobigny, Île-de-France Region, 93009, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • LE JEUNE Sylvain, MD

    Hôpital Avicenne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 29, 2016

Study Start

May 17, 2016

Primary Completion

November 14, 2019

Study Completion

November 14, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

FR(1)