Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
Study NCT ID:
NCT06888466
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention
Sponsor:
Catholic University of the Sacred Heart
Organization:
Study Overview
Official Title:
Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change
Status:
RECRUITING
Status Verified Date:
2025-09
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:
PHC
Brief Summary:
The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department.
Main Research Questions:
1. Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?
2. How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.
Participant will:
* Undergo genetic testing to assess their Polygenic Risk Score for CVDs
* receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
Main Research Questions:
1. Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?
2. How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.
Participant will:
* Undergo genetic testing to assess their Polygenic Risk Score for CVDs
* receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
Detailed Description:
This study aims to evaluate the efficacy of disclosing cardiovascular genetic risk-specifically through the Polygenic Risk Score (PRS)-in promoting the adoption of healthier lifestyle behaviors.
The enrollment period will last 18 months, with each participant taking part in the study for six months. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit, T2 or final visit at six months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals with a SCORE-2 \<10% or SCORE 2-OP \<15% will be invited to join the PHC pilot study.
Study Procedures Baseline Evaluations (T0)
After providing informed consent specific to the PHC study, participants will undergo the following assessments:
* Personal and Family History, Socioeconomic and Professional Status, and Demographic Information: a structured questionnaire will be administered at T0 to collect data on medical history, family history, socioeconomic and professional status, and demographic information.
* LE'8 Lifestyle Questionnaire: the Life's Essential 8 (LE'8) lifestyle questionnaire will be administered at T0 and T2. It generates a lifestyle score that categorizes participants into three groups: favorable, intermediate, or unfavorable. Validated in European populations and widely used in clinical studies, the scale ranges from 0 to 100.
* Medical Examination: includes biometric measurements such as BMI, body circumference, heart rate, and blood pressure.
* Blood Test Results: participants will provide recent blood test results (within the last six months) for lipid profiles, C-reactive protein (CRP), and glucose or hemoglobin A1c, which will be used to calculate the SCORE-2/SCORE 2-OP score.
* Blood Sampling: blood samples will be collected to perform genetic testing and assess cardiovascular disease risk through Polygenic Risk Scores (PRS).
* Anxiety Assessment (GAD-7): Participants will complete the Generalized Anxiety Disorder (GAD-7) questionnaire at T0 and T2 to assess anxiety levels.
* Work Ability: Participants will complete the Work Ability Index (WAI) questionnaire at T0 and T2 to assess their work ability.
Disclosure Visit (T1)
Approximately one month after T0, participants will undergo a telematic follow-up visit, during which:
* Their lifestyle score will be explained.
* Personalized preventive advice will be provided to encourage healthier lifestyle changes.
* PRS results will be disclosed, along with the corresponding genetic risk category (high, intermediate, or normal).
Follow-up Visit (T2)
Six months after the disclosure visit (T1), participants will undergo a comprehensive follow-up evaluation, which will include:
* Lifestyle Questionnaire: Assessment of lifestyle changes since T0.
* Recalculation of Lifestyle Category: Based on updated responses to the lifestyle questionnaire.
* Biometric Measurements: Includes weight, BMI, body circumference, heart rate, and blood pressure.
* Acceptability Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability of the intervention.
* Preferences on Technology Use: A questionnaire assessing participants' values and preferences regarding new technologies in healthcare.
* Genetic Testing Reaction (FACToR): A modified version of the MICRA questionnaire will be used to evaluate participants' reactions to genetic testing.
* WAI questionnaire to evaluate their work ability
The enrollment period will last 18 months, with each participant taking part in the study for six months. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit, T2 or final visit at six months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals with a SCORE-2 \<10% or SCORE 2-OP \<15% will be invited to join the PHC pilot study.
Study Procedures Baseline Evaluations (T0)
After providing informed consent specific to the PHC study, participants will undergo the following assessments:
* Personal and Family History, Socioeconomic and Professional Status, and Demographic Information: a structured questionnaire will be administered at T0 to collect data on medical history, family history, socioeconomic and professional status, and demographic information.
* LE'8 Lifestyle Questionnaire: the Life's Essential 8 (LE'8) lifestyle questionnaire will be administered at T0 and T2. It generates a lifestyle score that categorizes participants into three groups: favorable, intermediate, or unfavorable. Validated in European populations and widely used in clinical studies, the scale ranges from 0 to 100.
* Medical Examination: includes biometric measurements such as BMI, body circumference, heart rate, and blood pressure.
* Blood Test Results: participants will provide recent blood test results (within the last six months) for lipid profiles, C-reactive protein (CRP), and glucose or hemoglobin A1c, which will be used to calculate the SCORE-2/SCORE 2-OP score.
* Blood Sampling: blood samples will be collected to perform genetic testing and assess cardiovascular disease risk through Polygenic Risk Scores (PRS).
* Anxiety Assessment (GAD-7): Participants will complete the Generalized Anxiety Disorder (GAD-7) questionnaire at T0 and T2 to assess anxiety levels.
* Work Ability: Participants will complete the Work Ability Index (WAI) questionnaire at T0 and T2 to assess their work ability.
Disclosure Visit (T1)
Approximately one month after T0, participants will undergo a telematic follow-up visit, during which:
* Their lifestyle score will be explained.
* Personalized preventive advice will be provided to encourage healthier lifestyle changes.
* PRS results will be disclosed, along with the corresponding genetic risk category (high, intermediate, or normal).
Follow-up Visit (T2)
Six months after the disclosure visit (T1), participants will undergo a comprehensive follow-up evaluation, which will include:
* Lifestyle Questionnaire: Assessment of lifestyle changes since T0.
* Recalculation of Lifestyle Category: Based on updated responses to the lifestyle questionnaire.
* Biometric Measurements: Includes weight, BMI, body circumference, heart rate, and blood pressure.
* Acceptability Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability of the intervention.
* Preferences on Technology Use: A questionnaire assessing participants' values and preferences regarding new technologies in healthcare.
* Genetic Testing Reaction (FACToR): A modified version of the MICRA questionnaire will be used to evaluate participants' reactions to genetic testing.
* WAI questionnaire to evaluate their work ability
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: