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Poor enrollment due to insufficient study support.
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| Name | Class |
|---|---|
| Enverdis Corp. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiogoniometry and ECG Assessment | Other | The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Explorer | Device | ECG device which records comprehensive voltage potential data in the myocardium |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin A Zadeh, MD PhD MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Single study group. All patients are planned to undergo both tests, CGM and CT angiography. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Minimum data needed for this measure was not collected and therefore could not be calculated. | Posted | 30 days from CGM analysis |
|
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4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiogoniometry and ECG Assessment | The same patient will undergo both advanced ECG assessment using cardiogoniometry and standard ECG Explorer: ECG device which records comprehensive voltage potential data in the myocardium |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Armin Zadeh | Johns Hopkins University | 4105020549 | arminzadeh@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2015 | Jan 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
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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 |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Cardiac Risk Factors | Number of patients with traditional risk factors, i.e., Hypertension, Diabetes Mellitus, Hyperlipidemia, smoking will be recorded. | Count of Participants | Participants |
|
| Participants |
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| Secondary | 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 | Insufficient enrollment for analysis for this outcome measure | Posted | 30 days |
|
|
| Secondary | 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. | Insufficient enrollment for analysis of this outcome measure | Posted | 5 years after enrollment |
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| Secondary | Risk of Myocardial Infarction | Incidence of myocardial infarction at follow up | Insufficient enrollment for analysis of this outcome measure | Posted | 5 years after enrollment |
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| Secondary | Risk of Revascularization at Follow up | Incidence of revascularization at follow up | Insufficient enrollment for analysis of this outcome measure | Posted | 5 year after enrollment |
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| Secondary | Risk of Hospitalization | Incidence of hospitalization at follow up | Insufficient enrollment for analysis of this outcome measure | Posted | 5 years after enrollment |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D001157 |
| Arterial Occlusive Diseases |