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Not yet recruiting NCT07496775

Cardiovascular Acoustics for Early Disease Detection

Observational Valvular Heart Disease Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Valvular Heart Disease, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ACOUTECT: Cardiovascular Acoustics for Early Disease Detection

Overview

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.

Primary outcome measures

  • Discriminant score [Time frame: Investigations to be performed within six (6) months of one another.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07496775 · A097426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗