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Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases

NCT01743040 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1014

Last updated 2020-07-10

Study results available
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Summary

This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the sensitivity and specificity of the CADence device in detecting the existence of clinically significant coronary artery disease as determined by either standard or CT angiography.

Conditions

Interventions

DIAGNOSTIC_TEST

CADence

Patients with chest pain and two or more coronary risk factors and who were already indicated for nuclear stress test were enrolled in the study. The CADence was performed prior to nuclear stress test. Patients underwent standard angiogram based upon normal clinical judgement. In all other patients a CT angiogram followed. CADence is a handheld equipped with acoustic sensor technology, a patient booklet, remote algorithm and final report.

Sponsors & Collaborators

  • AUM Cardiovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Thomas, MD · University of California, Los Angeles

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-14
Primary Completion
2016-02-10
Completion
2016-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01743040 on ClinicalTrials.gov