Antiphospholipid SyndromeCOBRANCT03348306
Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome
A study testing MRI and Blood sample collection in people with Antiphospholipid Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- MRI and Blood sample collection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2018to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- MRI, Blood sample collection
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Brain and cardiac MRI in one time with gadolinium injection.
Blood sample collectionBiological
A blood sampling is also collected for hematocrit measure.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Device: MRI; Biological: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A brain or cardiac involvement will be defined by the identification of specific criteria visible by MRI.
Measured: Through study completion, in average of 24 months
Renal damage will be defined by the identification of a microalbuminuria> 30mg / L.
Measured: Through study completion, in average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start20 Jul 2018
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginie Dufrost, Central Hospital, Nancy, France
- Investigators
- Virginie DUFROST, Principal investigator, Nancy Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348306
- Sponsor's protocol ID
- 2017-A02345-48
- Acronym
- COBRA
- Status last verified
- Jan 2022
- First submitted
- 28 Aug 2017
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03348306
- Acronym / sponsor ID
- COBRA / 2017-A02345-48
- Conditions
- Antiphospholipid Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: MRI, Biological: Blood sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIBrain and cardiac MRI in one time with gadolinium injection. | Device | All patients |
| Blood sample collectionA blood sampling is also collected for hematocrit measure. | Biological | All patients |
Primary outcome
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
Renal damage will be defined by the identification of a microalbuminuria> 30mg / L.
Time frame: Through study completion, in average of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Related trials for Antiphospholipid Syndrome
Recruiting
Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study
Antiphospholipid Syndrome
RecruitingObservational study
Follow-up Cohort of Patients With Antiphospholipid Syndrome
Antiphospholipid Syndrome (APS)
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie DUFROST principal investigator
Nancy Academic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Blood sample collection in people with Antiphospholipid Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.