Noninvasive Real-Time Arterial Waveform Monitoring for Cardiovascular Disease Assessment

NCT07350629 | Recruiting

• 1 other identifier: 2025-APW-001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether noninvasive real-time arterial waveform monitoring can be used to assess cardiovascular diseases in adults. The main question it aims to answer is: Can photoacoustic imaging accurately capture arterial waveforms from patients' fingers? Can features extracted from the arterial waveforms reflect the type and severity of cardiovascular diseases? Participants will be asked to place their fingers into the imaging device, where their finger arterial pulse information will be noninvasively recorded.

Conditions

Aortic Stenosis Disease; Healthy Subjects; Aortic Regurgitation Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of the state of aortic regurgitation and aortic stenosis by photoacoustic tomography

  To determine the feasibility of using photoacoustic tomography to differentiate aortic regurgitation and aortic stenosis based on arterial waveform measurements.

  At enrollment (single time point)

Secondary Outcomes (3)

• Rise time of photoaocustic arterial waveform

  At enrollment (single time point)

• Decay time of photoaocustic arterial waveform

  At enrollment (single time point)

• Dicrotic notch time of photoaocustic arterial waveform

  At enrollment (single time point)

Study Arms (3)

Healthy Subjects

Healthy adult volunteers with no known cardiovascular disease will undergo noninvasive arterial waveform acquisition using the photoacoustic imaging device. No intervention is applied; data collection provides baseline waveform features for comparison with AR and AS patients.

Aortic Regurgitation (AR) Patients

Participants diagnosed with aortic regurgitation (AR) will undergo noninvasive arterial waveform acquisition using a photoacoustic imaging device. No intervention is applied; data collection focuses on capturing finger arterial pulse waveforms to assess features associated with AR.

Aortic Stenosis (AS) Patients

Participants diagnosed with aortic stenosis (AS) will undergo noninvasive arterial waveform acquisition using the same photoacoustic imaging device. No intervention is applied; data collection focuses on capturing finger arterial pulse waveforms to assess features associated with AS.

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 will be recruited from adult patients attending the cardiology department at the First Affiliated Hospital of University of Science and Technology of China, including individuals diagnosed with aortic regurgitation (AR) or aortic stenosis (AS), as well as healthy adult volunteers without known cardiovascular disease. Recruitment will focus on adults aged 18-80 years who are able to comply with finger arterial waveform measurement procedures.

You may qualify if:

• Age 18-80 years
• Able to provide informed consent
• For AR group: clinically diagnosed aortic regurgitation
• For AS group: clinically diagnosed aortic stenosis
• For healthy controls: no history of cardiovascular disease
• Able to undergo finger arterial waveform measurement

You may not qualify if:

• History of recent cardiac surgery or intervention (\<6 months)
• Hand disorders affecting finger mobility (e.g., arthritis)
• Pregnant or breastfeeding women
• Participation in other studies affecting arterial waveform
• Unable to understand or comply with study procedures

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

the First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230026, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: December 26, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

CN (1)