Valvular Heart DiseaseACOUTECTNCT07496775
Cardiovascular Acoustics for Early Disease Detection
An observational study of Valvular Heart Disease and Coronary Artery Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or leaky (regurgitation), known as heart valve disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease, Coronary Artery Disease
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2026to 31 Dec 2029
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to Department of Cardiology, Cambridge University NHS Foundation Trust.
Who may be able to join
- Participants aged ≥18 years
- Able to provide written, informed consent
- Has undergone angiography in the previous 6 months and scheduled to undergo transthoracic echocardiography, or has undergone transthoracic echocardiography in the previous 6 months and scheduled to undergo angiography, or is scheduled to undergo transthoracic echocardiography and angiography within 6 months.
- Angiography and echocardiography performed within Cambridge University Hospitals NHS Foundation Trust.
Who cannot join
- Haemodynamic instability
- STEMI or high risk NSTEMI
- Anginal symptoms at rest
- Heart failure symptoms with NYHA 4
- Cardiovascular related admission or event occurring between imaging studies
- Uncontrolled symptomatic arrhythmia
Show all 10Show fewer
- Acute pulmonary embolism
- Acute aortic dissection
- Previous valve intervention
- Suspected endocarditis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University NHS Foundation Trust
Cambridge, cb20qq
Jacob Brubert B Dr, MEng BMBCh MRCP PhD, 01223 805000, jacob.brubert@nhs.net
About this study
Official title: ACOUTECT: Cardiovascular Acoustics for Early Disease Detection
There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or leaky (regurgitation), known as heart valve disease.
There are two main types of imaging used to test for these conditions. Coronary artery disease can be diagnosed by taking X-ray pictures of a dye when injected into the blood vessels. In some cases the dye is injected into the veins and a CT scanner is used (CT coronary angiography), in others the dye is injected via a tube placed in the artery (invasive coronary angiography). Valvular heart disease is normally diagnosed using an echocardiogram (ultrasound of the heart).
In this study the investigators are looking for subtle changes in the sounds that come from the heart, which may allow heart disease to be detected earlier. The investigators are using a novel device, similar to a digital stethoscope, that has excellent sensitivity for heart sounds. Ultimately this may be used in community settings including GP surgeries, in this study the investigators are collecting sounds from patients undergoing routine scans as part of their workup for heart disease.
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Keywords
- coronary artery disease, valvular heart disease, ischemic heart disease, cardiovascular acoustics, heart sounds, cardiac auscultation
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease, Myocardial Ischemia
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 |
|---|---|---|
| Control | No valvular heart disease, no coronary artery disease | |
| Coronary artery disease | Significant coronary artery disease, no valvular heart disease | |
| Valvular heart disease | Significant valvular heart disease, no coronary artery disease | |
| Mixed disease | Significant coronary artery disease and significant valvular heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminant score
A discriminant score (minimum 0, maximum 1) for each of coronary artery disease and valvular heart disease will be generated by analysis of the phonographs.
Measured: Investigations to be performed within six (6) months of one another.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Jacob Brubert, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- James HF Rudd, PhD FRCP, Principal investigator, University of CambridgeJacob B Brubert, PhD MRCP, Study director, Cambridge University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496775
- Sponsor's protocol ID
- A097426
- Acronym
- ACOUTECT
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To reviewed following completion of pilot phase.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACOUTECT: Cardiovascular Acoustics for Early Disease Detection
- ClinicalTrials.gov ID
- NCT07496775
- Acronym / sponsor ID
- ACOUTECT / A097426
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Keywords
- coronary artery disease, valvular heart disease, ischemic heart disease, cardiovascular acoustics, heart sounds, cardiac auscultation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 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.
There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or leaky (regurgitation), known as heart valve disease.
There are two main types of imaging used to test for these conditions. Coronary artery disease can be diagnosed by taking X-ray pictures of a dye when injected into the blood vessels. In some cases the dye is injected into the veins and a CT scanner is used (CT coronary angiography), in others the dye is injected via a tube placed in the artery (invasive coronary angiography). Valvular heart disease is normally diagnosed using an echocardiogram (ultrasound of the heart).
In this study the investigators are looking for subtle changes in the sounds that come from the heart, which may allow heart disease to be detected earlier. The investigators are using a novel device, similar to a digital stethoscope, that has excellent sensitivity for heart sounds. Ultimately this may be used in community settings including GP surgeries, in this study the investigators are collecting sounds from patients undergoing routine scans as part of their workup for heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –No valvular heart disease, no coronary artery disease |
| Coronary artery disease | – | –Significant coronary artery disease, no valvular heart disease |
| Valvular heart disease | – | –Significant valvular heart disease, no coronary artery disease |
| Mixed disease | – | –Significant coronary artery disease and significant valvular heart disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Department of Cardiology, Cambridge University NHS Foundation Trust.
Key inclusion criteria (4 listed)
- Participants aged ≥18 years
- Able to provide written, informed consent
- Has undergone angiography in the previous 6 months and scheduled to undergo transthoracic echocardiography, or has undergone transthoracic echocardiography in the previous 6 months and scheduled to undergo angiography, or is scheduled to undergo transthoracic echocardiography and angiography within 6 months.
- Angiography and echocardiography performed within Cambridge University Hospitals NHS Foundation Trust.
Key exclusion criteria (10 listed)
- Haemodynamic instability
- STEMI or high risk NSTEMI
- Anginal symptoms at rest
- Heart failure symptoms with NYHA 4
- Cardiovascular related admission or event occurring between imaging studies
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
Discriminant score
Time frame: Investigations to be performed within six (6) months of one another.
A discriminant score (minimum 0, maximum 1) for each of coronary artery disease and valvular heart disease will be generated by analysis of the phonographs.
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided. To reviewed following completion of pilot phase.
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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.
James HF Rudd, PhD FRCP principal investigator
University of Cambridge
Jacob B Brubert, PhD MRCP study director
Cambridge University NHS Foundation Trust
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 Valvular Heart Disease and Coronary Artery Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 10 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 28 Oct 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 United Kingdom. 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?
Contact Stephen Kelleher (01223 217418, cuh.research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminant score (time frame: Investigations to be performed within six (6) months of one another.). 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 28 Oct 2026.