Cardiovascular DiseasesHEARTWISENCT06262828
HEARTWISE - P-CARDIAC for Chinese: Population-based Study
An observational study of Cardiovascular Diseases and CVD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, CVD
- How many people
- 3,800 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Apr 2024to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with established CVD visiting Queen Mary Hospital (QMH), Pok Oi Hospital (POH), Kwong Wah Hospital (KWH), Princess Margaret Hospital (PMH), Queen Elizabeth Hospital (QEH), Tuen Mun Hospital (TMH) during the study period will be recruited.
Who may be able to join
- Individuals aged 18 - 80 years old who visit the medical or cardiology SOPC clinics at the Queen Mary Hospital (QMH), Pok Oi Hospital (POH), Kwong Wah Hospital (KWH), Princess Margaret Hospital (PMH), Queen Elizabeth Hospital (QEH), Tuen Mun Hospital (TMH) and experienced prior CVD event (such as peripheral artery diseases, coronary heart diseases, myocardial infarction, stroke, revascularization) before the scheduled SOPC clinic visit date are eligible to participate in this study. Participants will be also able to comprehend English or Traditional Chinese as well.
Who cannot join
- People with history of dementia, psychiatric diseases or physical impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong
Sze Ling Celine Chui, PhD, (852) 3917 6629, cslchui@hku.hk
About this study
Official title: Harnessing Evidence And Real-world Data To Improve Cardiovascular Health and Services (HEARTWISE) - The Personalised - CARdiovascular DIsease Risk Assessment for Chinese (P-CARDIAC) Real World Evidence Study - Population-based Study
Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC.
Read the detailed description
This study has two parts to conduct for different outcomes.
Part one is a prospective population-based cohort study. Investigators hypothesize that patients with a higher frequency or larger number of types of cardiac event symptoms are likely to have a higher P-CARDIAC risk score. The correlation between P-CARDIAC risk score and the increasing in number of types and in number of times a patient reported to have heart disease symptoms, e.g. chest pain, shortness of breath, fatigue, swelling in legs, ankles or feet will be examined. The results reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Patients who are at a higher risk of recurrent CVD event are likely to have more medications and to have a sooner follow up appointment. At such, investigators also hypothesize a positive relationship between P-CARDIAC risk score and the number of class of medications prescribed and a negative correlation between P-CARDIAC risk score and the time to next SOPC follow up appointment.
Part two of the study will involve Delphi technique to determine P-CARDIAC risk thresholds with reference to current clinical management guideline such as American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline (AHA/ACC) and European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) (ESC/EAS), and this part will not involve patient contact. Investigators will compare the P-CARDIAC risk score and the clinician's rating of a patient's recurrent CVD risk on a 10% random subgroup of patients from part one in a "silent deployment" approach, ie, an individual patient's P-CARDIAC risk score will not be communicated to cardiologists. Cardiologists will be invited to rate if they think the patient is at high or low risk according to existing risk scores and the proposed treatment management and target based on treatment guidelines based on their experience. Each patient profile will be reviewed by at least 2 cardiologists and discussed to reach a consensus. Investigators will then evaluate the sensitivity of P-CARDIAC risk score with clinician's judgment. Prior to the commencement of Part two, investigators will collect insights from cardiologists regarding the interpretability of performance metrics and acceptable threshold of model performance for clinical practice. In addition, through this exercise, the research team will assist cardiologists to draft a guideline for follow up for patients at different risk level.
- Conditions
- Cardiovascular Diseases, CVD
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between P-CARDIAC risk score and heart disease related symptoms
We hypothesize that patients with a higher frequency or larger number of types of cardiac event symptoms are likely to have a higher P-CARDIAC risk score. The correlation between P-CARDIAC risk score and the increasing in number of types and in number of times a patient reported to have heart disease symptoms, e.g. chest pain, shortness of breath, fatigue, swelling in legs, ankles or feet will be examined.
Measured: From the date when participants join the project until the CVD outcomes confirmed in clinical setting or the date of death from any cause or the date of study ends whichever comes first, assessed up to 2 years.
P-CARDIAC risk thresholds determination
The study will involve Delphi technique to determine P-CARDIAC risk thresholds with reference to current clinical management guideline such as American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline (AHA/ACC) and European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) (ESC/EAS), and this part will not involve paricipants contact.
Measured: From the date when participants join the project until the date of death from any cause or the study ends whichever comes first, accessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start25 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sze Ling Celine Chui, The University of Hong Kong
- Investigators
- Sze Ling Celine Chui, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262828
- Sponsor's protocol ID
- CIRB-2024-240-3
- Acronym
- HEARTWISE
- Status last verified
- Oct 2024
- First submitted
- 31 Jan 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhiting G, Jiaying T, Haiying H, Yuping Z, Qunfei Y, Jingfen J. Cardiovascular disease risk prediction models in the Chinese population- a systematic review and meta-analysis. BMC Public Health. 2022 Aug 24;22(1):1608. doi: 10.1186/s12889-022-13995-z.
PubMed 35999550Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
PubMed 24222016Damman P, van 't Hof AW, Ten Berg JM, Jukema JW, Appelman Y, Liem AH, de Winter RJ. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: comments from the Dutch ACS working group. Neth Heart J. 2017 Mar;25(3):181-185. doi: 10.1007/s12471-016-0939-y.
PubMed 27966184Writing Committee Members; Drozda JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu BK, Olin JW, Ting HH; ACC/AHATask Force On Performance Measures; Heidenreich PA, Albert NM, Chan PS, Curtis LH, Ferguson TB Jr, Fonarow GC, Ho PM, O'Brien S, Russo AM, Thomas RJ, Ting HH, Varosy PD. 2015 ACC/AHA Focused Update of Secondary Prevention Lipid Performance Measures: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circ Cardiovasc Qual Outcomes. 2016 Jan;9(1):68-95. doi: 10.1161/HCQ.0000000000000014. Epub 2015 Dec 14. No abstract available.
PubMed 26666514Barrett D, Heale R. What are Delphi studies? Evid Based Nurs. 2020 Jul;23(3):68-69. doi: 10.1136/ebnurs-2020-103303. Epub 2020 May 19. No abstract available.
PubMed 32430290
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Evidence And Real-world Data To Improve Cardiovascular Health and Services (HEARTWISE) - The Personalised - CARdiovascular DIsease Risk Assessment for Chinese (P-CARDIAC) Real World Evidence Study - Population-based Study
- ClinicalTrials.gov ID
- NCT06262828
- Acronym / sponsor ID
- HEARTWISE / CIRB-2024-240-3
- Conditions
- Cardiovascular Diseases, CVD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Feb 2024 (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.
Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC.
Detailed description
This study has two parts to conduct for different outcomes.
Part one is a prospective population-based cohort study. Investigators hypothesize that patients with a higher frequency or larger number of types of cardiac event symptoms are likely to have a higher P-CARDIAC risk score. The correlation between P-CARDIAC risk score and the increasing in number of types and in number of times a patient reported to have heart disease symptoms, e.g. chest pain, shortness of breath, fatigue, swelling in legs, ankles or feet will be examined. The results reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Patients who are at a higher risk of recurrent CVD event are likely to have more medications and to have a sooner follow up appointment. At such, investigators also hypothesize a positive relationship between P-CARDIAC risk score and the number of class of medications prescribed and a negative correlation between P-CARDIAC risk score and the time to next SOPC follow up appointment.
Part two of the study will involve Delphi technique to determine P-CARDIAC risk thresholds with reference to current clinical management guideline such as American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline (AHA/ACC) and European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) (ESC/EAS), and this part will not involve patient contact. Investigators will compare the P-CARDIAC risk score and the clinician's rating of a patient's recurrent CVD risk on a 10% random subgroup of patients from part one in a "silent deployment" approach, ie, an individual patient's P-CARDIAC risk score will not be communicated to cardiologists. Cardiologists will be invited to rate if they think the patient is at high or low risk according to existing risk scores and the proposed treatment management and target based on treatment guidelines based on their experience. Each patient profile will be reviewed by at least 2 cardiologists and discussed to reach a consensus. Investigators will then evaluate the sensitivity of P-CARDIAC risk score with clinician's judgment. Prior to the commencement of Part two, investigators will collect insights from cardiologists regarding the interpretability of performance metrics and acceptable threshold of model performance for clinical practice. In addition, through this exercise, the research team will assist cardiologists to draft a guideline for follow up for patients at different risk level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with established CVD visiting Queen Mary Hospital (QMH), Pok Oi Hospital (POH), Kwong Wah Hospital (KWH), Princess Margaret Hospital (PMH), Queen Elizabeth Hospital (QEH), Tuen Mun Hospital (TMH) during the study period will be recruited.
Key inclusion criteria (1 listed)
- Individuals aged 18 - 80 years old who visit the medical or cardiology SOPC clinics at the Queen Mary Hospital (QMH), Pok Oi Hospital (POH), Kwong Wah Hospital (KWH), Princess Margaret Hospital (PMH), Queen Elizabeth Hospital (QEH), Tuen Mun Hospital (TMH) and experienced prior CVD event (such as peripheral artery diseases, coronary heart diseases, myocardial infarction, stroke, revascularization) before the scheduled SOPC clinic visit date are eligible to participate in this study. Participants will be also able to comprehend English or Traditional Chinese as well.
Key exclusion criteria (1 listed)
- People with history of dementia, psychiatric diseases or physical impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between P-CARDIAC risk score and heart disease related symptoms
Time frame: From the date when participants join the project until the CVD outcomes confirmed in clinical setting or the date of death from any cause or the date of study ends whichever comes first, assessed up to 2 years.
We hypothesize that patients with a higher frequency or larger number of types of cardiac event symptoms are likely to have a higher P-CARDIAC risk score. The correlation between P-CARDIAC risk score and the increasing in number of types and in number of times a patient reported to have heart disease symptoms, e.g. chest pain, shortness of breath, fatigue, swelling in legs, ankles or feet will be examined.
P-CARDIAC risk thresholds determination
Time frame: From the date when participants join the project until the date of death from any cause or the study ends whichever comes first, accessed up to 2 years.
The study will involve Delphi technique to determine P-CARDIAC risk thresholds with reference to current clinical management guideline such as American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline (AHA/ACC) and European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) (ESC/EAS), and this part will not involve paricipants contact.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 35999550Zhiting G, Jiaying T, Haiying H, Yuping Z, Qunfei Y, Jingfen J. Cardiovascular disease risk prediction models in the Chinese population- a systematic review and meta-analysis. BMC Public Health. 2022 Aug 24;22(1):1608. doi: 10.1186/s12889-022-13995-z.
- Background: PubMed 24222016Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 27966184Damman P, van 't Hof AW, Ten Berg JM, Jukema JW, Appelman Y, Liem AH, de Winter RJ. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: comments from the Dutch ACS working group. Neth Heart J. 2017 Mar;25(3):181-185. doi: 10.1007/s12471-016-0939-y.
- Background: PubMed 26666514Writing Committee Members; Drozda JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu BK, Olin JW, Ting HH; ACC/AHATask Force On Performance Measures; Heidenreich PA, Albert NM, Chan PS, Curtis LH, Ferguson TB Jr, Fonarow GC, Ho PM, O'Brien S, Russo AM, Thomas RJ, Ting HH, Varosy PD. 2015 ACC/AHA Focused Update of Secondary Prevention Lipid Performance Measures: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circ Cardiovasc Qual Outcomes. 2016 Jan;9(1):68-95. doi: 10.1161/HCQ.0000000000000014. Epub 2015 Dec 14. No abstract available.
- Background: PubMed 32430290Barrett D, Heale R. What are Delphi studies? Evid Based Nurs. 2020 Jul;23(3):68-69. doi: 10.1136/ebnurs-2020-103303. Epub 2020 May 19. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
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.
Sze Ling Celine Chui, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and CVD, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between P-CARDIAC risk score and heart disease related symptoms (time frame: From the date when participants join the project until the CVD outcomes confirmed in clinical setting or the date of death from any cause or the date of study ends whichever comes first, assessed up to 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06262828, which also lists 5 linked publications.
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 24 Oct 2024.