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Cost-effectiveness and Safety of the CADScorSystem in Patients With Symptoms Suggestive of Stable Coronary Artery Disease.

NCT04121949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2016

Last updated 2023-10-05

No results posted yet for this study

Summary

This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.

Conditions

  • Angina, Stable

Interventions

DEVICE

CADScor®System

The CADScor®System is a low cost, low resource-demanding, non-invasive, radiation-free device using highly advanced analysis of sounds originating from blood flow turbulence in the coronary circulation and myocardial motion. Heart sound recordings are obtained transcutaneously during a 3 minutes recording period with a microphone mounted at the IC4. A CAD-score on a scale from 0 to 99 is estimated immediately after the recording with a fully automated algorithm. The algorithm measures eight acoustic properties and the resulting acoustic score is combined with the clinical risk factors gender, age, and hypertension. The entire procedure lasts approximately 10 minutes.

Sponsors & Collaborators

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV

  • Larix A/S

    collaborator INDUSTRY

  • Acarix

    collaborator INDUSTRY

  • Kai Hansen Foundation

    collaborator OTHER

  • Kai Houmann Nielsens Fond

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Eva Prescott, DMSc. · Bispebjerg og Frederiksberg Hospitaler

  • Søren Galatius, DMSc. · Bispebjerg og Frederiksberg Hospitaler

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-09-15
Completion
2023-09-15

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121949 on ClinicalTrials.gov