PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty

NCT ID: NCT05798637

Last Updated: 2023-04-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-10

Study Completion Date

2023-11-30

Brief Summary

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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

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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).

Conditions

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Coronary Artery Disease Diabetes Mellitus, Type 2 Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Elderly subjects diagnosed with coronary syndrome ascertained by coronary angiography

Standard of care

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age \> 65 years
* low-dose aspirin therapy (100 mg)
* belonging to each of the cohorts indicated
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliera di Perugia

OTHER

Sponsor Role lead

Responsible Party

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Paolo Gresele

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Univeristà di Pavia

Pavia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Countries

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Italy

Central Contacts

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Paolo Gresele, Prof

Role: CONTACT

07.55783989

Marina Camera, Prof

Role: CONTACT

02.58002255

Facility Contacts

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Marina Camera, Prof

Role: primary

02.58002255

Marta Brambilla, PhD

Role: backup

02.58002766

Other Identifiers

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3546/19

Identifier Type: -

Identifier Source: org_study_id

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