Aging Clinical Trial
— report-AGEOfficial title:
Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals
Verified date | October 2023 |
Source | Istituto Nazionale di Ricovero e Cura per Anziani |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this research study is to collect clinical data, comprehensive geriatric assessment, risk factors, biological data and blood samples from inpatients aged 65 and older at the INRCA research hospitals (Italy). All data will be stored in a research bank and used to better clarify the mechanisms underlying the condition of "frailty" in aged patients. The database will be created on the INRCA server platform by establishing a safe HTTPS protocol.
Status | Enrolling by invitation |
Enrollment | 2250 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Aged 65 or older - Inpatients at the different INRCA research hospital facilities (Italy) Exclusion Criteria: - Inpatients who have not/for those the informed consent was not given |
Country | Name | City | State |
---|---|---|---|
Italy | INRCA Research Hospital | Ancona | |
Italy | INRCA Research Hospital | Casatenovo | |
Italy | INRCA Research Hospital | Cosenza | |
Italy | INRCA Research Hospital | Fermo |
Lead Sponsor | Collaborator |
---|---|
Istituto Nazionale di Ricovero e Cura per Anziani |
Italy,
Besdine RW, Wetle TF. Improving health for elderly people: an international health promotion and disease prevention agenda. Aging Clin Exp Res. 2010 Jun;22(3):219-30. doi: 10.1007/BF03324800. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Descriptive-epidemiological analysis of health conditions | Collection of a set of data and indicators of the health conditions including personal data, clinical-care, biological and diagnostic data, treatments/procedures and drug therapy. | participants will be followed for the duration of hospital stay, an expected average of 10 days | |
Secondary | Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument | identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests | within 24 hours from admission and within 24 hours prior to discharge | |
Secondary | Assessment of the functional capacities through specific performance tests | walking test, steps test, "chair standing", hand grip, articular extrusion | within 24 hours from admission and within 24 hours prior to discharge | |
Secondary | Evaluation of drugs consumption | Drugs prior to admission, Drugs administered during hospital stay, Prescribed drugs at discharge | within 24 hours from admission, during hospital stay and at discharge | |
Secondary | Identification of biomarkers: urinary markers of prostate disease | score PCA3mRNA/PSAmRNA | blood and urine samples drawn within 24 hours from admission | |
Secondary | Identification of biomarkers: immunological parameters | Leukocyte populations phenotype, Natural Killer activity in samples of leucocytes by means of citofluorimetric analysis | blood sample drawn within 24 hours from admission | |
Secondary | Identification of biomarkers: nutritional profile regarding trace elements | Identification of trace elements (Zn, Cu, Fe, Se) and alleles of genes that express proteins involved in their homeostasis (MT1A) | blood sample drawn within 24 hours from admission | |
Secondary | Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction | parameters of inflammation (pro- and anti-inflammatory cytokines: IL-6, IL-1, TNF-alpha, IL-10, IL-2, IL-17, IL-8; pro- and anti-inflammatory chemokines: MCP-1 and RANTES), parameters of oxidative stress (plasma total antioxidant capacity, determination of catalase, glutathione peroxidase, superoxide dismutase), and parameters of endothelial dysfunction (ADMA, SDMA, L-arginine, PAI-1) | blood sample drawn within 24 hours from admission | |
Secondary | Genetic analyses | assessment of: plasmatic and cellular (leukocytes) microRNA, mitochondrial DNA polymorphisms, length of telomeres of circulating leucocytes polymorphisms, epigenetic modifications of DNA in circulating leukocytes | blood sample drawn within 24 hours from admission | |
Secondary | Genomic wide testing | Genotyping by Affymetrix Genome-wide Human SNP array 6.0 will be performed by the Birdseed genotype calling algorithm, embedded in the Affymetrix Genotyping Console Software AGCS (Affymetrix), which is available at the Coordinating Center (INRCA). | blood sample drawn within 24 hours from admission |
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