Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

NCT02725671 | Terminated Results

• 1 other identifier: IRB00033908
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG acquisitions. Vectorcardiography has a long tradition in cardiology for providing comprehensive information on myocardial function and integrity. In recent years, computer assisted analysis has allowed automated interpretation of vectorcardiography with promising results in comparison to standard ECG for identifying patients with coronary heart disease. This study aims to investigate the utility of cardiogoniometry for noninvasively identifying patients who are at risk from coronary heart disease.

Conditions

Coronary Heart Disease; Coronary Artery Disease; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography

  Area under curve (AUC) analysis is proposed to be used to determine the diagnostic accuracy of cardiogoniometry for detecting patients with coronary heart disease as defined by at least one 50% or greater stenosis on CT coronary angiography.

  30 days from CGM analysis

Secondary Outcomes (5)

• Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography

  30 days

• Incidence of Death at Follow up

  5 years after enrollment

• Risk of Myocardial Infarction

  5 years after enrollment

• Risk of Revascularization at Follow up

  5 year after enrollment

• Risk of Hospitalization

  5 years after enrollment

Study Arms (1)

Cardiogoniometry and ECG Assessment

OTHER

The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG

Device: Explorer

Interventions

Explorer DEVICE

ECG device which records comprehensive voltage potential data in the myocardium

Cardiogoniometry and ECG Assessment

Eligibility Criteria

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

You may qualify if:

• Patients age 18 or older who are referred for elective cardiac CT examination for evaluation of coronary artery disease

You may not qualify if:

• hemodynamic instability
• history of anaphylactic contrast reaction
• inability of following breath hold instructions

Sponsors & Collaborators

• Johns Hopkins University: lead
• Enverdis Corp.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Dr. Armin Zadeh
• Organization: Johns Hopkins University

arminzadeh@jhu.edu

4105020549

Study Officials

• Armin A Zadeh, MD PhD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 1, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: June 26, 2020
• Last Updated: July 9, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-06

Locations

US (1)