HEARTWISE - P-CARDIAC for Chinese: Population-based Study

NCT06262828 | Recruiting

• 1 other identifier: CIRB-2024-240-3
• Study Type: observational
• Target: 3,800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; CVD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• People with history of dementia, psychiatric diseases or physical impairment.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• 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.

  PMID: 35999550 BACKGROUND

• Stone 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.

  PMID: 24222016 BACKGROUND

• Damman 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.

  PMID: 27966184 BACKGROUND

• Writing 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.

  PMID: 26666514 BACKGROUND

• Barrett 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.

  PMID: 32430290 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sze Ling Celine Chui, PhD

  School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)