Aortic Regurgitation DiseaseNCT07350629
Noninvasive Real-Time Arterial Waveform Monitoring for Cardiovascular Disease Assessment
An observational study of Aortic Regurgitation Disease and Aortic Stenosis Disease, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Regurgitation Disease, Aortic Stenosis Disease, Healthy Subjects
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to Feb 2026
- How long will I take part?
- 1 Day
- 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 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230026
Haoxin Gu, 86-18810938389, hxgu@mail.ustc.edu.cn
About this study
Official title: A Study on Noninvasive Real-Time Arterial Pressure Waveform Analysis for the Detection and Evaluation of Cardiovascular Diseases
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single time point)
Secondary outcomes (3)
Rise time of photoaocustic arterial waveform
To determine the systolic upstroke rise time of arterial waveforms using photoacoustic tomography
Measured: At enrollment (single time point)
Decay time of photoaocustic arterial waveform
To determine the diastolic decay time of arterial waveforms using photoacoustic tomography
Measured: At enrollment (single time point)
Dicrotic notch time of photoaocustic arterial waveform
To determine the dicrotic notch time of arterial waveforms using photoacoustic tomography
Measured: At enrollment (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Dec 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Regurgitation DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaojing, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350629
- Sponsor's protocol ID
- 2025-APW-001
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Noninvasive Real-Time Arterial Pressure Waveform Analysis for the Detection and Evaluation of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07350629
- Acronym / sponsor ID
- 2025-APW-001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Evaluation of the state of aortic regurgitation and aortic stenosis by photoacoustic tomography
Time frame: At enrollment (single time point)
To determine the feasibility of using photoacoustic tomography to differentiate aortic regurgitation and aortic stenosis based on arterial waveform measurements.
3 secondary outcomes
Rise time of photoaocustic arterial waveform
Time frame: At enrollment (single time point)
Decay time of photoaocustic arterial waveform
Time frame: At enrollment (single time point)
Dicrotic notch time of photoaocustic arterial waveform
Time frame: At enrollment (single time point)
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 20 Jan 2026.
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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.
the First Affiliated Hospital of University of Science and Technology of China
Hefei, China
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 Aortic Regurgitation Disease and Aortic Stenosis Disease, run by Anhui Provincial Cancer Hospital at 1 site in China.
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 6 inclusion and 5 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 20 Jan 2026. 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 China. 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?
Evaluation of the state of aortic regurgitation and aortic stenosis by photoacoustic tomography (time frame: At enrollment (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.