Coronary Artery DiseasePIPAFNCT05798637
PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty
An observational study of Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Azienda Ospedaliera di Perugia at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Alzheimer Disease
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Feb 2020to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- age > 65 years
- low-dose aspirin therapy (100 mg)
- belonging to each of the cohorts indicated
Who cannot join
- Lack of inclusion criteria and/or consent to the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, Milan, 20138
Marina Camera, Prof, 02.58002255, marina.camera@cardiologicomonzino.it
Marta Brambilla, PhD, 02.58002766, marta.brambilla@cardiologicomonzino.it
- Active, not recruiting
Univeristà di Pavia
Pavia, 27100
About this study
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
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.
Read the 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).
- Being tested
- Standard of care
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Alzheimer Disease, Platelets
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Elderly subjects diagnosed with coronary syndrome ascertained by coronary angiography Receives: Other: Standard of care | |
| Group B | Frail elderly Receives: Other: Standard of care | |
| Group C | Elderly subjects with type 2 diabetes mellitus Receives: Other: Standard of care | |
| Group D | Elderly subjects with alzheimer's disease Receives: Other: Standard of care | |
| Group E | Not frail elderly subjects Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (4)
Rate of systemic inflammation and oxidative stress
Quantification of oxidative stress and chronic inflammation will be done by measuring the levels of 8-hydroxy-2-deoxyguanosine (8-OHdG) and 8-epiPGF2a (8-isoprostane) on urine and the levels of high-sensitivity PCR, sCD40L, sRAGE, TAT and F1+2 in plasma by enzyme immunoassay method.
Measured: 3 years
Procoagulant platelet activity
Platelet procoagulant activity will be measured by quantifying thrombin generation from lysed platelets using the Calibrated Automated Thrombogram Assay
Measured: 3 years
Rate of proinflammatory platelet activity
Proinflammatory platelet capacity will be estimated by measuring the expression of matrix metalloproteinases MMP-2 and MMP-9.
Measured: 3 years
Rate of platelet heterogeneity
Platelets with procoagulant and proinflammatory activity will be identified by flowcytometry, and their transcripts/micro RNAs will be analyzed in the different patient groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start10 Feb 2020
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gresele, Azienda Ospedaliera di Perugia
- Investigators
- Paolo Gresele, Prof, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798637
- Sponsor's protocol ID
- 3546/19
- Acronym
- PIPAF
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05798637
- Acronym / sponsor ID
- PIPAF / 3546/19
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Alzheimer Disease, Platelets
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Standard of careElderly subjects diagnosed with coronary syndrome ascertained by coronary angiography |
| Group B | – | Other: Standard of careFrail elderly |
| Group C | – | Other: Standard of careElderly subjects with type 2 diabetes mellitus |
| Group D | – | Other: Standard of careElderly subjects with alzheimer's disease |
| Group E | – | Other: Standard of careNot frail elderly subjects |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (3 listed)
- age > 65 years
- low-dose aspirin therapy (100 mg)
- belonging to each of the cohorts indicated
Key exclusion criteria (1 listed)
- Lack of inclusion criteria and/or consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careNo 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) | Other | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Rate of platelet activation
Time frame: 3 years
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
4 secondary outcomes
Rate of systemic inflammation and oxidative stress
Time frame: 3 years
Procoagulant platelet activity
Time frame: 3 years
Rate of proinflammatory platelet activity
Time frame: 3 years
Rate of platelet heterogeneity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Gresele, Prof principal investigator
University Of Perugia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Azienda Ospedaliera di Perugia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Gresele, Prof (07.55783989, paolo.gresele@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of platelet activation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.