Trial Outcomes & Findings for Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography (NCT NCT02725671)

NCT ID: NCT02725671

Last Updated: 2020-07-09

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 30 days from CGM analysis
• Results posted on: 2020-07-09

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Study Group Single study group. All patients are planned to undergo both tests, Cardiogoniometry (CGM) and CT angiography.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

Baseline characteristics by cohort

Measure	Study Group n=2 Participants Single study group. All patients are planned to undergo both tests, CGM and CT angiography.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants
Cardiac Risk Factors	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days from CGM analysis

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Insufficient enrollment for analysis for this outcome measure

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years after enrollment

Population: Insufficient enrollment for analysis of this outcome measure

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years after enrollment

Population: Insufficient enrollment for analysis of this outcome measure

Incidence of myocardial infarction at follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 year after enrollment

Population: Insufficient enrollment for analysis of this outcome measure

Incidence of revascularization at follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years after enrollment

Population: Insufficient enrollment for analysis of this outcome measure

Incidence of hospitalization at follow up

Outcome measures

Outcome data not reported

Adverse Events

Cardiogoniometry and ECG Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Armin Zadeh

Johns Hopkins University

Phone: 4105020549

Email: arminzadeh@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place