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Clinical Trials/NCT02725671
NCT02725671
Terminated
Not Applicable

Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

Johns Hopkins University1 site in 1 country2 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Johns Hopkins University
Enrollment
2
Locations
1
Primary Endpoint
Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography
Status
Terminated
Last Updated
5 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
June 26, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 30 days from CGM analysis

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.

Secondary Outcomes

  • Risk of Hospitalization(5 years after enrollment)
  • 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)

Study Sites (1)

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