Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Coronary Heart Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: Explorer

Detailed Description

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. Compared to standard electrocardiography, vectorcardiography has shown to be more sensitive to detect structural and ischemic heart disease. Unfortunately, the interpretation of vectorcardiography is complex which has hindered its widespread application. In recent years, computer assisted analysis has allowed automated interpretation of vectorcardiography with promising results in comparison to standard ECG for identifying patients with ischemic heart disease. However, the underlying mechanisms and threshold of altered cardiac vectors in the presence of coronary artery disease are not well understood. This research aims at exploring the relationship of computer assisted analysis of vectorcardiography with the presence, extent, severity, and location of coronary artery disease in comparison to standard ECG evaluation. Furthermore, the investigators intent to follow up enrolled patients for the occurrence of adverse cardiovascular events for correlation with test findings. These data will provide comprehensive information on the diagnostic performance of noninvasive, inexpensive evaluation of cardiac vector loops for identifying patients at risk from coronary artery disease. Specifically, the study aims to:

1. Compare the diagnostic accuracy of cardiogoniometry with standard ECG for detecting coronary artery disease as assessed by CT angiography
2. Investigate the relationship between abnormal cardiogoniometry findings and the extent/severity/location of coronary artery disease by CT angiography
3. Compare the intermediate term prognosis of patients according to cardiogoniometry, standard ECG, and CT findings

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardiogoniometry and ECG Assessment; The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG	Device: Explorer; ECG device which records comprehensive voltage potential data in the myocardium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography	Area under the curve (AUC) analysis is proposed to be used to asses the diagnostic accuracy of CGM for identifying patients with any coronary atherosclerotic disease	30 days
Incidence of Death at Follow up	Patient follow up data will be used to performance of CGM to identify patients who are at risk of suffering adverse cardiac events at follow up compared to coronary CT angiography using AUC analysis.	5 years after enrollment
Risk of Myocardial Infarction	Incidence of myocardial infarction at follow up	5 years after enrollment
Risk of Revascularization at Follow up	Incidence of revascularization at follow up	5 year after enrollment
Risk of Hospitalization	Incidence of hospitalization at follow up	5 years after enrollment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Enverdis Corp.
• Investigators: Principal Investigator: Armin A Zadeh, MD PhD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IRB00033908

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No