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临床试验/NCT07502703
NCT07502703尚未招募不适用

Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community-Based Population in Semanan, Jakarta

Tarumanagara University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Agreement of rPPG-Derived Blood Pressure with Standard Measurements

研究概览

简要总结

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:

  1. Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements?
  2. 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:

  1. Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system
  2. Receive standard clinical assessments, including blood pressure and heart rate measurements
  3. 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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥30 years
  • Willing to participate and provide informed consent
  • Able to undergo face scan, clinical examination, and laboratory testing

排除标准

  • Facial abnormalities interfering with rPPG signal acquisition
  • Inability to remain still during measurement
  • Severe clinical instability
  • Incomplete key variables

研究组 & 干预措施

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.

结局指标

主要结局

Agreement of rPPG-Derived Blood Pressure with Standard Measurements

时间窗: 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).

Agreement of rPPG-Derived Heart Rate and Cardiac Workload

时间窗: Day 1

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).

Concordance of rPPG-Based ASCVD Risk with Standard Risk Calculation

时间窗: Day 1

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.

Concordance of rPPG-Derived Framingham Heart Age

时间窗: Day 1

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.

次要结局

未报告次要终点

研究者

发起方
Tarumanagara University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yohanes Firmansyah, dr, MH, MM

Principal Investigator

Tarumanagara University

研究点 (1)

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