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Search / Trial NCT04562142

A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study

Launched by AUSCULSCIENCES CANADA INC. · Sep 18, 2020

Trial Information

Current as of May 14, 2025

Unknown status

Keywords

ClinConnect Summary

This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Stable
  • 2. \>/= 19 years old
  • 3. Suspected obstructive CAD
  • 4. Referred to ICA
  • Exclusion Criteria:
  • 1. Documented CAD or coronary revascularization
  • 2. Age \< 19 years old
  • 3. Acute coronary syndromes
  • 4. Congenital heart disease or heart transplantation
  • 5. Dextrocardia
  • 6. Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (\>10/minute))
  • 7. Resting heart rate \> 110 bpm
  • 8. Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
  • 9. Chest wall deformity or wounds in adhesive application areas
  • 10. Pregnancy
  • 11. Unwillingness or inability to provide informed consent or to comply with the study protocol

About Ausculsciences Canada Inc.

AuscultSciences Canada Inc. is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Specializing in the evaluation of novel therapeutic interventions, the company leverages cutting-edge technology and a robust network of clinical sites to facilitate high-quality, patient-centered studies. Committed to regulatory compliance and ethical standards, AuscultSciences Canada Inc. collaborates with healthcare professionals and stakeholders to generate reliable data that drives informed decision-making in the medical community. With a focus on improving patient outcomes, the organization seeks to contribute significantly to the advancement of medical science and public health.

Locations

Ottawa, Ontario, Canada

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Ben Chow, MD

Principal Investigator

Ottawa Heart Institue Research Foundation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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