cPSTA System CADLAD Study

This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. In addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. The performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. In this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥21 years of age at the time of screening
Meets criteria for coronary angiography
Scheduled to undergo cardiac catheterization with coronary angiography
Ability to understand the requirements of the study and to provide written informed consent

Exclusion criteria

Prior documented myocardial infarction (MI)
Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
Previous heart valve replacement
Previous sustained or paroxysmal atrial or ventricular arrhythmia
Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
Implantable Neuro-stimulators
Congenital Heart Disease
Pregnancy (breast feeding)
Currently taking any Type IA, IC or III antiarrhythmic
Any history of Amiodarone therapy
Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
Breast implants
Neuromuscular Disease if the condition results in tremor or muscle fasciculations

Treatment and study plan

Phase Signal Recorder

Device

The cPSTA System is a medical device system that uses passive tomography to analyze a patient's phase space data to identify the presence of significant coronary artery disease. The cPSTA System consists of several components that work together to obtain, transmit, analyze the data, and display the results, including the Phase Signal Acquisition System (PSAQ System), which is the Phase Signal Recorder (PSR) and the Phase Signal Data Repository (PSDR); analytical software; and secure web portal. For this study only the PSAQ System is used by the clinical site for the purposes of acquiring and transmitting the signal.

Other names: PSR

Primary outcomes

Machine-learned algorithm

Time frame: 7 day

Develop and test a machine-learned algorithm which maximizes the area under the receiver-operating characteristic (AUC-ROC) curve to 0.70 (expected) and clinically significant sensitivity and specificity to detect CAD when compared to clinical diagnosis of significant coronary artery disease (i.e., presence of ≥70% stenosis by angiography or reduced fraction flow of <=0.80) in at least one of the major coronary arteries (LMA, LAD, RCA, or LCX) or their distributions.

Sponsors and collaborators

Lead sponsor

Analytics For Life

Industry

Registry information

Official study title

Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study

Acronym: CADLAD

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: May 27, 2016
Registry last updated: Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed