Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05883878
Status:
RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-05-17
Brief Title:
Innovative Approaches for Personalised Cardiovascular Prevention
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Innovative Approaches for Personalised Cardiovascular Prevention Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service NHS Implementation
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INNOPREV
Brief Summary:
The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases CVD in the population The main questions it aims to answer are
efficacy and safety of the intervention
how to implement the interventions in the NHS
Participants will be randomized in one of the four parallel arms
standard of care
genetic testing for cardiovascular genetic risk through the cardiovascular Polygenic Risk Score or PRS
digital intervention with a wearable device and its app
digital intervention and genetic testing PRS
The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline alone or in combination with the use of a wearable device on two endpoints i change in lifestyle pattern ii CVD risk profile modification The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline nor respect to subjects receiving traditional risk assessment plus adopting wearable devices
efficacy and safety of the intervention
how to implement the interventions in the NHS
Participants will be randomized in one of the four parallel arms
standard of care
genetic testing for cardiovascular genetic risk through the cardiovascular Polygenic Risk Score or PRS
digital intervention with a wearable device and its app
digital intervention and genetic testing PRS
The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline alone or in combination with the use of a wearable device on two endpoints i change in lifestyle pattern ii CVD risk profile modification The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline nor respect to subjects receiving traditional risk assessment plus adopting wearable devices
Detailed Description:
The trial will consist of four phases an enrollment phase T0 a disclosure visit three weeks later T1 a follow-up visit five months after the disclosure visit T2 and a final follow-up twelve months from enrollment T3
Once enrolled T0 all participants will sign the informed consent form and undergo a comprehensive assessment which includes
Completing a questionnaire on socioeconomic status area of residence and lifestyle using the Lifes Essential 8 tool 1 The questionnaire will cover smoking status alcohol consumption dietary pattern sleep pattern and physical activity Participants will be classified into favorable intermediate or unfavorable individual lifestyle patterns according to the Lifes Essential 8 score
Blood analysis will be performed to evaluate the lipid profile including total cholesterol LDL cholesterol HDL cholesterol and triglycerides
At T1 a disclosure visit will be conducted to explain the assigned lifestyle category share the results of the blood tests and provide information on the expected interventions based on the assigned group
The questionnaire will be administered at T0 T2 and T3 Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3
Once enrolled T0 all participants will sign the informed consent form and undergo a comprehensive assessment which includes
Completing a questionnaire on socioeconomic status area of residence and lifestyle using the Lifes Essential 8 tool 1 The questionnaire will cover smoking status alcohol consumption dietary pattern sleep pattern and physical activity Participants will be classified into favorable intermediate or unfavorable individual lifestyle patterns according to the Lifes Essential 8 score
Blood analysis will be performed to evaluate the lipid profile including total cholesterol LDL cholesterol HDL cholesterol and triglycerides
At T1 a disclosure visit will be conducted to explain the assigned lifestyle category share the results of the blood tests and provide information on the expected interventions based on the assigned group
The questionnaire will be administered at T0 T2 and T3 Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None