CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,014 enrolled
Drug / intervention
CADenceother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01743040
NCT01743040N/ACompleted
CompareCT.gov

Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases

AUM Cardiovascular, Inc.·observational·Posted Dec 6, 2012·Updated Jul 10, 2020

In Brief

An observational study evaluating CADence for Coronary Artery Disease. Completed, enrolled 1,014 participants across 24 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartJun 14, 2013
Primary CompletionFeb 10, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.6 years ago

Interventions

CADenceother

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.