Cardiovascular Acoustics for Early Disease Detection | NCT07496775

Studies
Cardiovascular Acoustics for Early Disease Detection

NCT07496775

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Status

Not yet recruiting

Last Update Posted

Apr 1, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Valvular Heart Disease
Coronary Artery Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Mar 23, 2026

First Submission Date that Met QC Criteria

Mar 23, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Apr 1, 2026Actual

Name	Class
University of Cambridge	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Investigations to be performed within six (6) months of one another.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Acute pulmonary embolism
Acute aortic dissection
Previous valve intervention
Suspected endocarditis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to Department of Cardiology, Cambridge University NHS Foundation Trust.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephen Kelleher	Contact	01223 217418		cuh.research@nhs.net

Overall Officials

Name	Affiliation	Role
James HF Rudd, PhD FRCP	University of Cambridge	Principal Investigator
Jacob B Brubert, PhD MRCP	Cambridge University NHS Foundation Trust	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

To reviewed following completion of pilot phase.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases
D003324	Coronary Artery Disease
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided