Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02725671
• Collaborator: Enverdis Corp. (Other)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 62.9
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease; Coronary Artery Disease; Ischemic Heart Disease	Device: Explorer	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Jun 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Cardiogoniometry and ECG Assessment 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

Outcome Measures

Primary Outcome Measures

1. Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography [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 Outcome Measures

1. Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography [30 days]

   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

2. Incidence of Death at Follow up [5 years after enrollment]

   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.

3. Risk of Myocardial Infarction [5 years after enrollment]

   Incidence of myocardial infarction at follow up

4. Risk of Revascularization at Follow up [5 year after enrollment]

   Incidence of revascularization at follow up

5. Risk of Hospitalization [5 years after enrollment]

   Incidence of hospitalization at follow up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Enverdis Corp.

Investigators

• Principal Investigator: Armin A Zadeh, MD PhD MPH, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2015

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02725671
• Other Study ID Numbers: IRB00033908
• First Posted: Apr 1, 2016
• Last Update Posted: Jul 9, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases

Study Results

Participant Flow

Arm/Group Title	Study Group
Arm/Group Description	Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
Period Title: Overall Study
STARTED	2
COMPLETED	1
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Study Group
Arm/Group Description	Single study group. All patients are planned to undergo both tests, CGM and CT angiography.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%
Cardiac Risk Factors (Count of Participants)
Count of Participants [Participants]	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Minimum data needed for this measure was not collected and therefore could not be calculated.

Arm/Group Title	Study Group
Arm/Group Description	Single study group. All patients are planned to undergo both tests, CGM and CT angiography.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Insufficient enrollment for analysis for this outcome measure

Arm/Group Title	Study Group
Arm/Group Description	Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
Measure Participants	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Insufficient enrollment for analysis of this outcome measure

Arm/Group Title	Study Group
Arm/Group Description	Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
Measure Participants	0

4. Secondary Outcome

Title	Risk of Myocardial Infarction
Description	Incidence of myocardial infarction at follow up
Time Frame	5 years after enrollment

Outcome Measure Data

Analysis Population Description

Insufficient enrollment for analysis of this outcome measure

Arm/Group Title	Cardiogoniometry and ECG Assessment
Arm/Group Description	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
Measure Participants	0

5. Secondary Outcome

Title	Risk of Revascularization at Follow up
Description	Incidence of revascularization at follow up
Time Frame	5 year after enrollment

Outcome Measure Data

Analysis Population Description

Insufficient enrollment for analysis of this outcome measure

Arm/Group Title	Cardiogoniometry and ECG Assessment
Arm/Group Description	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
Measure Participants	0

6. Secondary Outcome

Title	Risk of Hospitalization
Description	Incidence of hospitalization at follow up
Time Frame	5 years after enrollment

Outcome Measure Data

Analysis Population Description

Insufficient enrollment for analysis of this outcome measure

Arm/Group Title	Cardiogoniometry and ECG Assessment
Arm/Group Description	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
Measure Participants	0

Adverse Events

Time Frame	4 years
Arm/Group Title	Cardiogoniometry and ECG Assessment
Arm/Group Description	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
All Cause Mortality
	Cardiogoniometry and ECG Assessment
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Cardiogoniometry and ECG Assessment
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Cardiogoniometry and ECG Assessment
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.