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

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ClinicalTrials.gov Identifier: NCT01569334
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2012
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Allograft Vasculopathy Biological: blood samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy
Study Start Date : February 2011
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : November 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
HTC with Cardiac allograft vasculopathy
HTC:heart transplanted recipients
 Biological: blood samples
HTR without Cardiac allograft vasculopathy Biological: blood samples
untransplanted Biological: blood samples


Outcome Measures
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Primary Outcome Measures :
  1. Analysis of endothelial lesion-repair biomarkers [ Time Frame: 24 MONTHS ]
    through phenotypic and quantitative analysis of circulating endothelial progenitors subsets and (repair potential)


Secondary Outcome Measures :
  1. Analysis of anti endothelial NK innate immune responses parameters [ Time Frame: 24 MONTTHS ]
    • Anti endothelial, anti HLA anti MIC antibody detection in recipient' serum by luminex and flow cytometry
    • Evaluation of soluble Fractalkine and MIC levels in serum through ELISA
    • Analysis of CX3CR1 and CD16 polymorphism and phenotypic NK cell surface expression
    • Assay of serum induced and natural NK cell cytotoxicity against coronary and endothelial cell targets


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569334


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01569334     History of Changes
Other Study ID Numbers: 2010-A01145-34
2010 18 ( Other Identifier: AP HM )
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
identify early non invasive markers that index the endothelial lesion/ regeneration potential in association with CAV in heart transplanted recipients (HTR)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases