Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy
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Purpose
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 | Intervention |
|---|---|
|
Cardiac Allograft Vasculopathy |
Biological: blood samples |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy |
- Analysis of endothelial lesion-repair biomarkers [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]through phenotypic and quantitative analysis of circulating endothelial progenitors subsets and (repair potential)
- Analysis of anti endothelial NK innate immune responses parameters [ Time Frame: 24 MONTTHS ] [ Designated as safety issue: No ]
- 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
| Estimated Enrollment: | 170 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HTC with Cardiac allograft vasculopathy
HTC:heart transplanted recipients
|
Biological: blood samples |
| HTR without Cardiac allograft vasculopathy | Biological: blood samples |
| untransplanted | Biological: blood samples |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: JEAN PAUL BERNARD | jpbernard@ap-hm.fr |
| France | |
| Assistance Publique Hopitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: jean-paul BERNARD | |
| Principal Investigator: ANNICK MOULY BANDINI | |
| Study Director: | BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE |
| ClinicalTrials.gov Identifier: | NCT01569334 History of Changes |
| Other Study ID Numbers: | 2010-A01145-34, 2010 18 |
| Study First Received: | February 14, 2011 |
| Last Updated: | April 2, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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) |
ClinicalTrials.gov processed this record on May 16, 2013