Repository of Phase Signals for Algorithm Development and Testing in CAD in CHINA

NCT04034537 | Unknown

• 1 other identifier: CADC-CIP-001
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to build a repository of resting cardiac phase space signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography for the purposes of machine-learning and testing algorithms developed by Analytics 4 Life. Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; cardiac Phase Space Tomography Analysis; ischemia

Outcome Measures

Primary Outcomes (2)

• positive coronary artery disease

  significant stenosis measured by coronary angiography

  7 day after index procedure

• positive cardiac Phase Space Tomography Analysis

  positive result measured by cardiac Phase Space Tomography Analysis

  7 day after index procedure

Study Arms (1)

cPSTA GROUP

EXPERIMENTAL

Patients who meet the study's inclusion and exclusion criteria, including signing the informed consent form, subjects will undergo cardiac Phase Space Tomography Analysis (cPSTA) signal acquisition prior to their scheduled cardiac catheterization on the day of the procedure.

Diagnostic Test: cPSTA

Interventions

cPSTA DIAGNOSTIC_TEST

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. All enrolled patients will perform cPSTA signal recording.

Also known as: PSR

cPSTA GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old
• 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

You may not qualify if:

• Prior coronary artery bypass grafting (CABG)
• Prior heart valve replacement
• Previous sustained or paroxysmal atrial or ventricular arrythmia;
• 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
• Pregnant or breast feeding
• Currently taking any Type IA, IC or III antiarrhythmics
• Any history of amiodarone use
• Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum)
• Breast implants
• Neuromuscular Disease if the condition results in tremor or muscle fasciculations

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juying Qian, M.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbo Yang, M.D.

CONTACT

008613585890793; yang.hongbo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients are planned to perform coronary angiography without contraindications.

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: July 26, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share