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

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 |
- Analysis of endothelial lesion-repair biomarkers [ Time Frame: 24 MONTHS ]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 ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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)

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
France | |
Assistance Publique Hopitaux de Marseille | |
Marseille, France |
Study Director: | BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille |
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 |