Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03914079

Acronym

CAD-det

Enrollment

2000

Registered

2019-04-16

Start date

2019-04-05

Completion date

2022-12-31

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Coronary Artery Disease

Keywords

Coronary Artery Disease, Cardiovascular Disease, Atherosclerosis, Coronary Occlusion, Non-Invasive Medical Device, Cardiac Diagnostics

Brief summary

The primary purpose of this multi-center study is to collect and study the acoustic and electrical signals created by the heart during the cardiac cycle as a result of stenosis or plaque associated with coronary artery disease (CAD).

Detailed description

This research intends to evaluate acoustic and electrical cardiovascular signals in patients with known or suspected CAD and establish the ability of the CAD-det System to accurately and reliably detect them utilizing coronary computed tomography (CCTA) and invasive coronary angiography (ICA) as reference standards. In addition, this study will collect clinical and acoustic data of other cardiac pathologies to better understand their impact on the acoustic signatures associated with CAD.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 19 years; 2. Suspected or known CAD; 3. Able and willing to comply with the study procedures; 4. Referred to ICA or CCTA for CAD characterization; 5. Willingness and ability to sign the Informed Consent Form.

Exclusion criteria

1. Unwillingness or inability to provide informed consent; 2. Age less than 19 years; 3. Pregnancy; 4. Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants suspected of having Coronary Artery Disease	up to 1 Year	Collection of all acoustic cardiac data to allow for the acoustic discrimination of the presence and degree of CAD in diseased and healthy participants.

Secondary

Measure	Time frame	Description
Estimation of coronary artery stenosis by the CAD-det device.	up to 1 year	CAD-det results will be categorized by sex as: 1. Acoustic and electrical signals consistent with 0-30% diameter stenosis (Negative for CAD); 2. Acoustic and electrical signals consistent with 31-49% diameter stenosis (Pr-clinical / Negative); 3. Acoustic and electrical signals consistent with 50-69% diameter stenosis (Positive); 4. Acoustic and electrical signals consistent with 70% or greater diameter stenosis (Positive); and 5. Equivocal or non-diagnostic.
Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:	up to 1 year	1. 0 - 30% diameter stenosis (Negative); 2. 31 - 49% diameter stenosis (Negative / Pre-clinical); 3. 50 - 69% diameter stenosis (Positive); 4. 70% or greater diameter stenosis (Positive); and 5. Equivocal In cases where a participant undergoes both CCTA and ICA, the ICA results shall serve as the reference method results used for statistical analysis of the diagnostic accuracy of CAD-det. In participants with equivocal ICA and when invasive coronary physiology or functional assessments (eg. FFR, iFR, Pd/Pa, RFR) are performed, these assessments will be used to ascertain if the CAD-det can determine functional (hemodynamically significant) CAD.

Countries

Canada

Outcome results