search
Back to results

Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome (COBRA)

Primary Purpose

Antiphospholipid Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Blood sample collection
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Antiphospholipid Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years,
  • Patients with documented primary thrombotic and / or obstetrical APS that respond to the revised Sapporo-Sydney classification criteria
  • Person affiliated to a social security insurance,
  • Person who have received complete information about the organization of the research and have signed informed consent,
  • Person who has carried out a suitable clinical examination prior to the research.

Exclusion Criteria:

  • Personal history of myocardial infarction, ischemic stroke or severe renal insufficiency,
  • Patients with a contraindication to MRI: in particular implantable cardiac pacemakers or defibrillators, implanted pumps, cochlear implants, neurosurgical clips, intraorbital or brain metallic foreign material,
  • Impossibility to perform the MRI examination, especially claustrophobic patients, or with a morphotype that does not allow access to MRI (abdominal diameter too large),
  • Patient with a contraindication to Gadolinium injection: severe renal insufficiency, allergy to Gadolinium salts (precautions for use in patients at high risk of convulsions),
  • APS associated with autoimmune disease (systemic lupus erythematosus according to American College of Rheumatology criteria),
  • Patient with known microalbuminuria > 30mg/L,
  • Women of childbearing age who do not have effective contraception,

  • Persons referred to in Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the French Public Health Code :

    • Pregnant, parturient or nursing mother
    • Person deprived of liberty by judicial or administrative decision
    • Person undergoing psychiatric care
    • Person admitted to a health or social institution for other purposes than research
    • Minor person (not emancipated)
    • A major person under a measure of legal protection (guardianship, curator, safeguard of justice)
    • Person in an emergency situation
    • A major person who is unable to express his / her consent and is not under a juridical protection

Sites / Locations

  • CHRU Nancy Brabois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Outcomes

Primary Outcome Measures

A brain or cardiac involvement will be defined by the identification of specific criteria visible by MRI.
Renal damage will be defined by the identification of a microalbuminuria> 30mg / L.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2017
Last Updated
January 20, 2022
Sponsor
Central Hospital, Nancy, France
search

1. Study Identification

Unique Protocol Identification Number
NCT03348306
Brief Title
Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome
Acronym
COBRA
Official Title
Assessement of a Multi-organ Screening Procedure for the Detection of Pre-clinical Ischaemia in Antiphospholipid Syndrome The COBRA Study (CardiO-Brain Renal Involvement in Antiphospholipid Syndrome)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of recurrence. The current challenge is the identification of patients at high risk of organ damage that directly impact morbidity and mortality. Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was shown that the detection of asymptomatic ischemic events identify patients at risk for symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic complications. The investigators' hypothesis is that a significant proportion of patients with APS would have asymptomatic organ involvement. Objectives The primary objective is to determine the frequency of asymptomatic target organ (s) (heart, brain, kidney) in APS patients. Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii) to identify the factors associated with asymptomatic target organ lesion, (iii) to describe the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to assess the feasibility of a one-time cardiovascular and brain MRI. Methods and analysis This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical study. The investigators expect to include 50 consecutive patients with APS followed in the department of Vascular Medicine at Nancy University Hospital. Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For each patient, the number of target organs involvements will be calculated and the frequencies will be compared by Fisher or chi-2 tests.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Brain and cardiac MRI in one time with gadolinium injection.
Intervention Type
Biological
Intervention Name(s)
Blood sample collection
Intervention Description
A blood sampling is also collected for hematocrit measure.
Primary Outcome Measure Information:
Title
A brain or cardiac involvement will be defined by the identification of specific criteria visible by MRI.
Time Frame
Through study completion, in average of 24 months
Title
Renal damage will be defined by the identification of a microalbuminuria> 30mg / L.
Time Frame
Through study completion, in average of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, Patients with documented primary thrombotic and / or obstetrical APS that respond to the revised Sapporo-Sydney classification criteria Person affiliated to a social security insurance, Person who have received complete information about the organization of the research and have signed informed consent, Person who has carried out a suitable clinical examination prior to the research. Exclusion Criteria: Personal history of myocardial infarction, ischemic stroke or severe renal insufficiency, Patients with a contraindication to MRI: in particular implantable cardiac pacemakers or defibrillators, implanted pumps, cochlear implants, neurosurgical clips, intraorbital or brain metallic foreign material, Impossibility to perform the MRI examination, especially claustrophobic patients, or with a morphotype that does not allow access to MRI (abdominal diameter too large), Patient with a contraindication to Gadolinium injection: severe renal insufficiency, allergy to Gadolinium salts (precautions for use in patients at high risk of convulsions), APS associated with autoimmune disease (systemic lupus erythematosus according to American College of Rheumatology criteria), Patient with known microalbuminuria > 30mg/L, Women of childbearing age who do not have effective contraception, Persons referred to in Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the French Public Health Code : Pregnant, parturient or nursing mother Person deprived of liberty by judicial or administrative decision Person undergoing psychiatric care Person admitted to a health or social institution for other purposes than research Minor person (not emancipated) A major person under a measure of legal protection (guardianship, curator, safeguard of justice) Person in an emergency situation A major person who is unable to express his / her consent and is not under a juridical protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie DUFROST
Organizational Affiliation
Nancy Academic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy Brabois
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome

We'll reach out to this number within 24 hrs