PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty

Azienda Ospedaliera di Perugia

Status: Enrolling

Conditions: Coronary Artery Disease; Alzheimer Disease; Diabetes Mellitus, Type 2

Treatments: Other: Standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT05798637

3546/19

Details and patient eligibility

About

This is a prospective observational study aimed at testing the existence of an association between frailty, inflammatory status, and degree of platelet activation and reactivity in elderly subjects with type 2 diabetes or coronary artery disease or Alzheimer's disease.

Full description

Frailty in the elderly is a syndrome that strongly affects quality of life and represents a major social and economic challenge. Frailty often, and more frequently, occurs in individuals with aging-related diseases including type 2 diabetes, cardiovascular disease, and Alzheimer's disease. All of these diseases are associated with a state of weak chronic inflammation. Studies in recent years have pointed out that platelets can directly contribute to inflammatory processes. Due to of this ability to act as proinflammatory cells and of their strong involvement in various metabolic, cardiovascular, and neurodegenerative disorders, platelets appear to have key roles in the physio-pathological mechanisms that predispose to frailty.

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age > 65 years
• low-dose aspirin therapy (100 mg)
• belonging to each of the cohorts indicated

Exclusion criteria

• Lack of inclusion criteria and/or consent to the study

Trial design

200 participants in 5 patient groups

Group A

Description:

Elderly subjects diagnosed with coronary syndrome ascertained by coronary angiography

Treatment:

Other: Standard of care

Group B

Description:

Frail elderly

Treatment:

Other: Standard of care

Group C

Description:

Elderly subjects with type 2 diabetes mellitus

Treatment:

Other: Standard of care

Group D

Description:

Elderly subjects with alzheimer's disease

Treatment:

Other: Standard of care

Group E

Description:

Not frail elderly subjects

Treatment:

Other: Standard of care