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Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy

NCT ID: NCT01569334

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-11-30

Brief Summary

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Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.

Detailed Description

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Conditions

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Cardiac Allograft Vasculopathy

Keywords

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identify early non invasive markers that index the endothelial lesion/ regeneration potential in association with CAV in heart transplanted recipients (HTR)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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HTC with Cardiac allograft vasculopathy

HTC:heart transplanted recipients

Group Type OTHER

blood samples

Intervention Type BIOLOGICAL

HTR without Cardiac allograft vasculopathy

Group Type OTHER

blood samples

Intervention Type BIOLOGICAL

untransplanted

Group Type OTHER

blood samples

Intervention Type BIOLOGICAL

Interventions

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blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject \> 18 years at the time of the inclusion,
* Subject having benefited from a heart transplant more than 11 months ago in the service of cardiac surgery concerned whatever is the treatment to immunosuppresseur current
* Subject benefiting from a coronarography within the framework of their surveillance comment-Clerk's Office beyond 12 months
* Subject having given their consent
* Affiliated to the Social Security

\* HTC with Cardiac allograft vasculopathy:
* Subject with coronaropathies diagnosed by the coronarography

\* TC without Cardiac allograft vasculopathy:
* Subject without coronaropathies diagnosed by the coronarography

\* untransplanted
* Untreated Subject by immunosuppresseurs
* Subject without antécédaent of transfusion
* Subject without history of transplantations
* Subject with coronaropathies diagnosed by a coronarography

Exclusion Criteria

* Presenting a contraindication to the coronarography
* Subject refusing to practise the examination of coronarography
* Subject reaches(affects) of a cancer other one than cutaneous
* Subject achieves of hepatic Incapacity (ALAT and\\or ASAT \> 3N)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

References

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Paul P, Picard C, Sampol E, Lyonnet L, Di Cristofaro J, Paul-Delvaux L, Lano G, Nicolino-Brunet C, Ravis E, Collart F, Dignat-George F, Dussol B, Sabatier F, Mouly-Bandini A. Genetic and Functional Profiling of CD16-Dependent Natural Killer Activation Identifies Patients at Higher Risk of Cardiac Allograft Vasculopathy. Circulation. 2018 Mar 6;137(10):1049-1059. doi: 10.1161/CIRCULATIONAHA.117.030435. Epub 2017 Nov 2.

Reference Type DERIVED
PMID: 29097449 (View on PubMed)

Other Identifiers

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2010 18

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A01145-34

Identifier Type: -

Identifier Source: org_study_id