Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

Johns Hopkins University

Status: Terminated

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Heart Disease

Treatments: Device: Explorer

Study type: Interventional

Funder types: Other

Identifiers

NCT02725671

IRB00033908

Details and patient eligibility

About

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.

Full 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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Cardiogoniometry and ECG Assessment

Other group

Description:

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

Treatment:

Device: Explorer