Trial Outcomes & Findings for Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System (NCT NCT03103061)

Last Updated: 2019-08-09

Results Overview

Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated. This outcome measure data value represents the number of adverse events that occurred during this study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

30 days +/- 3 days

Results posted on

2019-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Subject Enrollment Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Subject Enrollment n=24 Participants Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants
Race (NIH/OMB) White	18 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	24 participants n=99 Participants

PRIMARY outcome

Timeframe: 30 days +/- 3 days

Outcome measures

Outcome measures
Measure	Standard Subject Enrollment n=24 Participants Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
Number of Treatment-related Adverse Events	6 Adverse events

SECONDARY outcome

Timeframe: Immediately following CT perfusion imaging.

Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.

Outcome measures

Outcome measures
Measure	Standard Subject Enrollment n=24 Participants Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician.
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment Sensitivity	85.7 Percent
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment Specificity	70.6 Percent
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment Accuracy	75 Percent

Adverse Events

Standard Subject Enrollment

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

Hunter Gray, Program Coordinator

Medical University of South Carolina

Phone: 843-876-3185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place