Serum and Cellular Biomarkers for Aortic Valve Stenosis
NCT04312139 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 280
Last updated 2022-10-04
Summary
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical treatment). Two independent clinical cohorts of patients will provide serum samples, along with tissue and serum of a validated animal model of the disease for evaluation of the early stages, in order to develop and validate a multiplexed Enzyme-linked Immunosorbent Assay kit (multiplex ELISA). Advanced bioinformatics analysis will facilitate the selection of the most promising molecules from integrated proteomics-transcriptomics-metabolomics data. The novel biomarkers will help clinicians to early diagnose patients at high risk and will pave the way for the experimental implementation of promising pharmaceutical therapies.
Moreover, AthenaValve aims to shed light on the systemic cellular interplay of the same patients, by analyzing the circulating immune cell phenotypes of the subgroups of rapid and slow progression patients
Conditions
- Calcific Aortic Valve Disease
- Aortic Valve Stenosis
- Aortic Valve, Calcification of
Interventions
- DIAGNOSTIC_TEST
-
Echocardiography
Baseline and prospective follow-up echocardiography
- DIAGNOSTIC_TEST
-
Computerized Tomography Aortic Valve Calcium Score
Baseline and prospective follow-up CT calcium score of aortic valve
- OTHER
-
Untargeted LC/MS and LC-MS/MS
Serum samples untargeted proteomics and metabolomics
- OTHER
-
Targeted LC/MS and LC-MS/MS
Serum samples targeted proteomics and metabolomics
- DIAGNOSTIC_TEST
-
multiplex ELISA
Implementation of novel multiplex ELISA assay on serum samples of aortic valve stenosis prospective cohort.
Sponsors & Collaborators
-
Naval Hospital of Athens
collaborator UNKNOWN -
Biomedical Research Foundation of the Academy of Athens
collaborator UNKNOWN -
University of Oxford
collaborator OTHER -
National and Kapodistrian University of Athens
lead OTHER
Principal Investigators
-
Konstantinos P Toutouzas, Professor · First Department of Cardiology, Athens Medical School, NKUA
Eligibility
- Min Age
- 60 Years
- Max Age
- 87 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2025-03-31
- Completion
- 2025-09-30
Countries
- Greece
Study Locations
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