PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty
PIPAF
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
1 other identifier
observational
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 6, 2023
April 1, 2023
3.7 years
March 23, 2023
April 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of platelet activation
Platelet activation will be assessed in vivo, on circulating platelets, by flowcytometry measurement of p-selectin, integrin αIIbβ3, and tissue factor expression, and in vitro, on isolated platelets, by studying the response to agonists (thrombin, ADP, collagen) with lumiaggregometry and ATP secretion
3 years
Secondary Outcomes (4)
Rate of systemic inflammation and oxidative stress
3 years
Procoagulant platelet activity
3 years
Rate of proinflammatory platelet activity
3 years
Rate of platelet heterogeneity
3 years
Study Arms (5)
Group A
Elderly subjects diagnosed with coronary syndrome ascertained by coronary angiography
Group B
Frail elderly
Group C
Elderly subjects with type 2 diabetes mellitus
Group D
Elderly subjects with alzheimer's disease
Group E
Not frail elderly subjects
Interventions
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
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).
You may qualify if:
- age \> 65 years
- low-dose aspirin therapy (100 mg)
- belonging to each of the cohorts indicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IRCCS Centro Cardiologico Monzino
Milan, Milan, 20138, Italy
Univeristà di Pavia
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Gresele, Prof
University Of Perugia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 4, 2023
Study Start
February 10, 2020
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
April 6, 2023
Record last verified: 2023-04