Trial Outcomes & Findings for Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System (NCT NCT02308475)

NCT ID: NCT02308475

Last Updated: 2018-07-06

Results Overview

The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 1 Day
• Results posted on: 2018-07-06

Participant Flow

Participant milestones

Measure	Myocardial Stress CT Perfusion Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System

Baseline characteristics by cohort

Measure	Myocardial Stress CT Perfusion n=2 Participants Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart
Age, Continuous	34.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	0 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
Height	67 inches n=5 Participants
Weight	248.5 lbs n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: The planned statistical analyses were not performed.

The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: The planned statistical analyses were not performed.

Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: The planned statistical analyses were not performed.

Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.

Outcome measures

Outcome data not reported

Adverse Events

Myocardial Stress CT Perfusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Myocardial Stress CT Perfusion n=2 participants at risk Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart

General disorders Chest Pain

50.0% 1/2 • Number of events 1 • 6 months

Additional Information

Brian Jacobs - Program Assistant

Medical University of South Carolina

Phone: 843-876-4922

Email: jacobsbr@musc.edu

Results disclosure agreements

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