Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
Primary Purpose
Coronary Heart Disease, Coronary Artery Disease, Ischemic Heart Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Explorer
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Heart Disease
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiogoniometry and ECG Assessment
Arm Description
The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Risk of Myocardial Infarction
Incidence of myocardial infarction at follow up
Risk of Revascularization at Follow up
Incidence of revascularization at follow up
Risk of Hospitalization
Incidence of hospitalization at follow up
Full Information
NCT ID
NCT02725671
First Posted
March 10, 2016
Last Updated
June 26, 2020
Sponsor
Johns Hopkins University
Collaborators
Enverdis Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02725671
Brief Title
Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
Official Title
Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment due to insufficient study support.
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
June 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Enverdis Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Compare the diagnostic accuracy of cardiogoniometry with standard ECG for detecting coronary artery disease as assessed by CT angiography
Investigate the relationship between abnormal cardiogoniometry findings and the extent/severity/location of coronary artery disease by CT angiography
Compare the intermediate term prognosis of patients according to cardiogoniometry, standard ECG, and CT findings
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Coronary Artery Disease, Ischemic Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiogoniometry and ECG Assessment
Arm Type
Other
Arm Description
The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG
Intervention Type
Device
Intervention Name(s)
Explorer
Intervention Description
ECG device which records comprehensive voltage potential data in the myocardium
Primary Outcome Measure Information:
Title
Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography
Description
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.
Time Frame
30 days from CGM analysis
Secondary Outcome Measure Information:
Title
Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography
Description
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
Time Frame
30 days
Title
Incidence of Death at Follow up
Description
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.
Time Frame
5 years after enrollment
Title
Risk of Myocardial Infarction
Description
Incidence of myocardial infarction at follow up
Time Frame
5 years after enrollment
Title
Risk of Revascularization at Follow up
Description
Incidence of revascularization at follow up
Time Frame
5 year after enrollment
Title
Risk of Hospitalization
Description
Incidence of hospitalization at follow up
Time Frame
5 years after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin A Zadeh, MD PhD MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
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