PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty
NCT ID: NCT05798637
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-02-10
2023-11-30
Brief Summary
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Detailed Description
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In the present study, it is planned to recruit 4 cohorts of elderly patients, each of 40 patients, divided by pathology ( frail elderly, diabetic elderly, elderly with stable atherosclerotic coronary artery disease, elderly with early-stage Alzheimer's disease) and a cohort of 40 healthy elderly subjects. All subjects will perform a blood draw at enrollment and after 24 months of follow up in order to evaluate: the state of platelet activation; the aggregating response of platelets to stimuli such as thrombin, Adenosine DiPhosphate (ADP), and collagen; the state of chronic inflammation and oxidative stress; the procoagulant profile of platelets; presence of platelet subpopulations characterized by RNA, microRNA and/or protein profiling. Each subject will also be given a questionnaire to assess frailty status (according to Fried's criteria) and urine samples will be collected to perform the assay of metabolites such as 11dh-TXB, 8-hydroxy-2-deoxyguanosine (8-OHdG) and 8-epiPGF2a (8-isoprostane).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A
Elderly subjects diagnosed with coronary syndrome ascertained by coronary angiography
Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Group B
Frail elderly
Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Group C
Elderly subjects with type 2 diabetes mellitus
Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Group D
Elderly subjects with alzheimer's disease
Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Group E
Not frail elderly subjects
Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Interventions
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Standard of care
No treatment other than clinical standard therapy is provided. Each subjects will perform a blood draw at enrollment and after 24 months of follow-up. Subjects will also be given a frailty status assessment questionnaire (according to the criteria of Fried)
Eligibility Criteria
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Inclusion Criteria
* low-dose aspirin therapy (100 mg)
* belonging to each of the cohorts indicated
65 Years
ALL
Yes
Sponsors
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Azienda Ospedaliera di Perugia
OTHER
Responsible Party
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Paolo Gresele
Clinical Professor
Principal Investigators
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Paolo Gresele, Prof
Role: PRINCIPAL_INVESTIGATOR
University Of Perugia
Locations
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IRCCS Centro Cardiologico Monzino
Milan, Milan, Italy
Univeristà di Pavia
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3546/19
Identifier Type: -
Identifier Source: org_study_id
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