An interventional study of Explorer in Coronary Heart Disease, Coronary Artery Disease and Ischemic Heart Disease, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Diagnostic
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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 2 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
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
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.
Time frame: 30 days from CGM analysis
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
Time frame: 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.
Time frame: 5 years after enrollment
Risk of Myocardial Infarction
Incidence of myocardial infarction at follow up
Time frame: 5 years after enrollment
Risk of Revascularization at Follow up
Incidence of revascularization at follow up
Time frame: 5 year after enrollment
Risk of Hospitalization
Incidence of hospitalization at follow up
Time frame: 5 years after enrollment
| Milestone | Study Group |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Incidence of myocardial infarction at follow up
No measurements were reported for this outcome.
Incidence of revascularization at follow up
No measurements were reported for this outcome.
Incidence of hospitalization at follow up
No measurements were reported for this outcome.
Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cardiogoniometry and ECG Assessment | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Study Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 1 |
| Age, Continuous(years) | Study Group |
|---|---|
| Mean | 56 (44 to 68) |
| Sex: Female, Male(Participants) | Study Group |
|---|---|
| Female | 0 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Study Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Study Group |
|---|---|
| United States | 2 |
| Cardiac Risk Factors(Participants) | Study Group |
|---|---|
| Count of participants | 2 |
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