- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496775
Cardiovascular Acoustics for Early Disease Detection (ACOUTECT)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stephen Kelleher
- Phone Number: 01223 217418
- Email: cuh.research@nhs.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Investigations to be performed within six (6) months of one another.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James HF Rudd, PhD FRCP, University of Cambridge
- Study Director: Jacob B Brubert, PhD MRCP, Cambridge University NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A097426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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