Clinical trial NCT05798637: PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty
Official title: Role of Inflammation in the Pathogenesis of Frailty in the Elderly: Studies on the Contribution of Blood Platelets- PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Diabetes Mellitus, Type 2
Alzheimer Disease
Keywords: Coronary Artery Disease
Diabetes Mellitus, Type 2
Alzheimer Disease
Platelets
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study involves 5 cohorts of patients:

* patients diagnosed with stable ischemic heart disease (CAD)
* frail elderly patients
* patients with type 2 diabetes (T2DM)
* patients with Alzheimer's disease (AD)
* not frail elderly subjects (control group).

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of platelet activation
timeFrame: 3 years
Secondary outcomes:
measure: Rate of systemic inflammation and oxidative stress
timeFrame: 3 years
measure: Procoagulant platelet activity
timeFrame: 3 years
measure: Rate of proinflammatory platelet activity
timeFrame: 3 years
measure: Rate of platelet heterogeneity
timeFrame: 3 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Centro Cardiologico Monzino
state: Milan
city: Pavia
country: Italy
facility: Univeristà di Pavia
Study officials:
affiliation: University Of Perugia
name: Paolo Gresele, Prof
role: PRINCIPAL_INVESTIGATOR
References: