NCT07496775

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2029

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 23, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

coronary artery diseasevalvular heart diseaseischemic heart diseasecardiovascular acousticsheart soundscardiac auscultation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Valve DiseasesCoronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • James HF Rudd, PhD FRCP

    University of Cambridge

    PRINCIPAL INVESTIGATOR
  • Jacob B Brubert, PhD MRCP

    Cambridge University NHS Foundation Trust

    STUDY DIRECTOR

Central Study Contacts

Stephen Kelleher

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Clinical Fellow

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

April 1, 2026

Record last verified: 2026-03