- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502703
Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community
Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community-Based Population in Semanan, Jakarta
The goal of this observational study is to evaluate whether a contactless camera-based technology, called remote photoplethysmography (rPPG), can accurately measure cardiovascular parameters and estimate cardiovascular risk in adults aged 30 years and older living in a community setting in Semanan, Jakarta. This study aims to determine if rPPG can be used as a simple and accessible tool for early cardiovascular screening.
The main questions it aims to answer are:
- Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements?
- Do cardiovascular risk estimates generated by rPPG (such as ASCVD risk and Framingham heart age) correspond to risk calculations obtained using conventional clinical and laboratory methods?
Researchers will compare results obtained from rPPG-based facial video scans with results from standard medical assessments, including blood pressure measurements, heart rate evaluation, and laboratory tests for cholesterol levels, to determine the level of agreement and accuracy.
Participants will:
- Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system
- Receive standard clinical assessments, including blood pressure and heart rate measurements
- Provide basic health information (such as age, sex, smoking status, and treatment history) Undergo simple laboratory testing for cholesterol levels
This study is expected to help determine whether rPPG can be used as a reliable, non-invasive, and scalable screening tool for cardiovascular risk in community and primary healthcare settings.
Study Overview
Status
Detailed Description
Introduction Remote photoplethysmography (rPPG) is an emerging contactless technology that enables extraction of physiological signals from facial video, allowing estimation of cardiovascular parameters such as heart rate and blood pressure. With the growing burden of atherosclerotic cardiovascular disease (ASCVD), early and accessible risk screening tools are essential, particularly in community settings with limited access to laboratory-based assessments. Although established risk models such as the ASCVD and Framingham scores are widely used, their application often requires clinical and laboratory data that may not be readily available. The integration of rPPG-based measurements with cardiovascular risk estimation offers a promising approach; however, its clinical validity and agreement with standard methods remain insufficiently explored .
Objective This study aims to evaluate the agreement and concordance between rPPG-derived cardiovascular parameters and standard clinical measurements, as well as to assess the alignment of rPPG-estimated ASCVD risk and Framingham heart age with conventional risk calculations.
Methods This study will use an analytical observational cross-sectional design conducted in Kelurahan Semanan, Jakarta. Adult participants (≥30 years) will be recruited through community-based sampling. Each participant will undergo clinical anamnesis, physical examination (blood pressure and heart rate), and laboratory testing (total cholesterol and HDL). In parallel, rPPG-based facial video scans will be performed under standardized conditions to obtain systolic and diastolic blood pressure, mean arterial pressure, pulse pressure, heart rate, cardiac workload, ASCVD risk, and Framingham heart age. Framingham risk will be calculated using sex-specific equations based on clinical and laboratory variables. Agreement between rPPG and standard measurements will be assessed using Bland-Altman analysis, while correlations will be evaluated using Pearson or Spearman tests. Concordance for categorical risk classification will be analyzed using Cohen's Kappa.
Expected Results It is expected that rPPG-derived heart rate will demonstrate good agreement with standard measurements, while blood pressure parameters will show moderate agreement. Additionally, rPPG-based ASCVD risk and Framingham heart age are anticipated to exhibit acceptable concordance with conventional risk calculations. These findings may support the potential role of rPPG as a preliminary screening and risk stratification tool in community-based and telemedicine settings.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexander Halim Santoso, MD
- Phone Number: +6281381606869
- Email: alexanders@fk.untar.ac.id
Study Contact Backup
- Name: Ernawati Ernawati, Dr
- Phone Number: +6281389048199
- Email: ernawati@fk.untar.ac.id
Study Locations
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Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonesia
- Kelurahan Semanan
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Contact:
- Wenny Sanwani
- Phone Number: +6281585013412
- Email: wenny.sanwani@gmail.com
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Contact:
- Hanna Wijaya
- Phone Number: +6281223787878
- Email: hannwijaya@yahoo.com
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Principal Investigator:
- Ernawati Ernawati
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Sub-Investigator:
- Enny Irawaty
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Sub-Investigator:
- Zita Atzmardina
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Principal Investigator:
- Alexander Halim Santoso
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Sub-Investigator:
- Wikrama Lokapradhana
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Sub-Investigator:
- Amita Pradhani
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Sub-Investigator:
- William Kuswandi
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Sub-Investigator:
- Alya Dwiana
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Sub-Investigator:
- David Wongso
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Sub-Investigator:
- Diana Dinali
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Sub-Investigator:
- Muhammad Fikri Dzakwan
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Sub-Investigator:
- Clement Drew
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Sub-Investigator:
- Silviana Tirtasari
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Sub-Investigator:
- Triyana Sari
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Sub-Investigator:
- Steve Geraldo Bustam
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Sub-Investigator:
- Bryan Anna Wijaya
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥30 years
- Willing to participate and provide informed consent
- Able to undergo face scan, clinical examination, and laboratory testing
Exclusion Criteria:
- Facial abnormalities interfering with rPPG signal acquisition
- Inability to remain still during measurement
- Severe clinical instability
- Incomplete key variables
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Community Adults Undergoing rPPG and Standard Cardiovascular Assessment
This cohort includes adults aged ≥30 years residing in Semanan, Jakarta, recruited through community-based sampling.
Participants will undergo both index testing using remote photoplethysmography (rPPG) via facial video scan and reference standard assessments, including blood pressure measurement, heart rate evaluation, and laboratory testing (total cholesterol and HDL).
Additional data such as age, sex, smoking status, and antihypertensive treatment will be collected.
There is no intervention applied; all procedures are non-invasive and observational.
The study aims to compare rPPG-derived cardiovascular parameters and risk estimates (ASCVD risk and Framingham heart age) with standard clinical measurements to assess agreement and validity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement of rPPG-Derived Blood Pressure with Standard Measurements
Time Frame: Day 1
|
Assessment of agreement between systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and pulse pressure obtained from rPPG-based facial video analysis and standard measurements using aneroid or digital sphygmomanometers.
Agreement will be evaluated using Bland-Altman analysis (mean difference and limits of agreement).
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Day 1
|
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Agreement of rPPG-Derived Heart Rate and Cardiac Workload
Time Frame: Day 1
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Evaluation of agreement between heart rate and cardiac workload obtained from rPPG and those measured using standard methods (palpation and pulse oximetry).
Agreement will be analyzed using Bland-Altman and correlation analysis (Pearson/Spearman).
|
Day 1
|
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Concordance of rPPG-Based ASCVD Risk with Standard Risk Calculation
Time Frame: Day 1
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Assessment of agreement and concordance between ASCVD risk (%) and risk categories (low, intermediate, high) estimated using rPPG and those calculated using conventional clinical and laboratory data.
Concordance will be evaluated using Cohen's Kappa and correlation analysis.
|
Day 1
|
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Concordance of rPPG-Derived Framingham Heart Age
Time Frame: Day 1
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Evaluation of agreement between Framingham heart age estimated using rPPG-derived parameters and heart age calculated using standard Framingham risk equations based on clinical and laboratory variables.
Agreement will be assessed using correlation and Bland-Altman analysis.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Wongso, DexWellness
- Study Director: Yohanes Firmansyah, Universitas Tarumanagara
- Principal Investigator: Ernawati Ernawati, Universitas Tarumanagara
- Study Director: Alexander Halim Santoso, Universitas Tarumanagara
- Study Director: Ratheesh Nair, Watch Your Health
- Study Chair: Sri Tiarti, Universitas Tarumanagara
- Study Chair: Noer Saelan Tadjudin, Universitas Tarumanagara
- Principal Investigator: Clement Drew, Universitas Tarumanagara
- Study Director: Zita Atzmardina, Universitas Tarumanagara
- Study Director: Andria Priyana, Universitas Tarumanagara
- Study Chair: Putu Tommy Yudha Sumatera Suyasa, Universitas Tarumanagara
- Study Director: Kieren Nathan Wong, Monash University
- Study Director: Jaydee Kirani Wong, Melbourne University
- Study Chair: Meiske Yunithree Suparman, Universitas Tarumanagara
Publications and helpful links
General Publications
- Debnath U, Kim S. A comprehensive review of heart rate measurement using remote photoplethysmography and deep learning. Biomed Eng Online. 2025 Jun 20;24(1):73. doi: 10.1186/s12938-025-01405-5.
- van Es VAA, Lopata RGP, Scilingo EP, Nardelli M. Contactless Cardiovascular Assessment by Imaging Photoplethysmography: A Comparison with Wearable Monitoring. Sensors (Basel). 2023 Jan 29;23(3):1505. doi: 10.3390/s23031505.
- Shetty NS, Gaonkar M, Patel N, Vekariya N, Li P, Arora G, Arora P. PREVENT and Pooled Cohort Equations in Mortality Risk Prediction: National Health and Nutrition Examination Survey. JACC Adv. 2024 Dec 26;3(12):101372. doi: 10.1016/j.jacadv.2024.101372. eCollection 2024 Dec.
- Pandey A, Mehta A, Paluch A, Ning H, Carnethon MR, Allen NB, Michos ED, Berry JD, Lloyd-Jones DM, Wilkins JT. Performance of the American Heart Association/American College of Cardiology Pooled Cohort Equations to Estimate Atherosclerotic Cardiovascular Disease Risk by Self-reported Physical Activity Levels. JAMA Cardiol. 2021 Jun 1;6(6):690-696. doi: 10.1001/jamacardio.2021.0948.
- Nguyen QD, Odden MC, Peralta CA, Kim DH. Predicting Risk of Atherosclerotic Cardiovascular Disease Using Pooled Cohort Equations in Older Adults With Frailty, Multimorbidity, and Competing Risks. J Am Heart Assoc. 2020 Sep 15;9(18):e016003. doi: 10.1161/JAHA.119.016003. Epub 2020 Sep 2.
- Muntner P, Colantonio LD, Cushman M, Goff DC Jr, Howard G, Howard VJ, Kissela B, Levitan EB, Lloyd-Jones DM, Safford MM. Validation of the atherosclerotic cardiovascular disease Pooled Cohort risk equations. JAMA. 2014 Apr 9;311(14):1406-15. doi: 10.1001/jama.2014.2630.
- Mora S, Wenger NK, Cook NR, Liu J, Howard BV, Limacher MC, Liu S, Margolis KL, Martin LW, Paynter NP, Ridker PM, Robinson JG, Rossouw JE, Safford MM, Manson JE. Evaluation of the Pooled Cohort Risk Equations for Cardiovascular Risk Prediction in a Multiethnic Cohort From the Women's Health Initiative. JAMA Intern Med. 2018 Sep 1;178(9):1231-1240. doi: 10.1001/jamainternmed.2018.2875.
- Khera R, Pandey A, Ayers CR, Carnethon MR, Greenland P, Ndumele CE, Nambi V, Seliger SL, Chaves PHM, Safford MM, Cushman M, Xanthakis V, Vasan RS, Mentz RJ, Correa A, Lloyd-Jones DM, Berry JD, de Lemos JA, Neeland IJ. Performance of the Pooled Cohort Equations to Estimate Atherosclerotic Cardiovascular Disease Risk by Body Mass Index. JAMA Netw Open. 2020 Oct 1;3(10):e2023242. doi: 10.1001/jamanetworkopen.2020.23242.
- Chin JW, Chan PHD, Chen S, Cheng CH, So RHY, Chow E, Fok BSP, Wong KL. Clinical Validation of rPPG-Enabled Contactless Pulse Rate Monitoring Software in Cardiovascular Disease Patients. Bioengineering (Basel). 2026 Feb 20;13(2):246. doi: 10.3390/bioengineering13020246.
- Allado E, Poussel M, Moussu A, Hily O, Temperelli M, Cherifi A, Saunier V, Bernard Y, Albuisson E, Chenuel B. Accurate and Reliable Assessment of Heart Rate in Real-Life Clinical Settings Using an Imaging Photoplethysmography. J Clin Med. 2022 Oct 17;11(20):6101. doi: 10.3390/jcm11206101.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Lipid Metabolism Disorders
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Chest Pain
- Angina Pectoris
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Hypertension
- Heart Diseases
- Diabetes Mellitus
- Coronary Artery Disease
- Dyslipidemias
- Angina, Stable
Other Study ID Numbers
- 20260325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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