Use of Lexiscan for Myocardial Stress Perfusion Computed... | NCT03103061

NCT03103061

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Astellas Pharma US, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Myocardial Stress CT Perfusion	Experimental	Low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator).	Drug: Lexiscan

Name	Type	Description	Arm Group Labels	Other Names
Lexiscan	Drug	Coronary vasodilator	Myocardial Stress CT Perfusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Treatment-related Adverse Events	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.	30 days +/- 3 days

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment	Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.	Immediately following CT perfusion imaging.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician.
Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
Subject must be 18 - 85 years of age.
Subject must provide written informed consent prior to any study-related procedures being performed.
Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
- By surgical sterilization, or
- Post menopausal, with minimum one (1) year history without menses.
Subject has severe asthma or COPD requiring frequent inhaler use.
Subject has prior diagnosis of obstructive CAD that has not been revascularized.
Subject with implanted rhythm devices (pacemaker, defibrillator).
Subject has significant arrhythmia.
Subject has high grade heart block.
Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has consumed caffeine within the last 12 hours.
Subject has an acute psychiatric disorder.
Subject is unwilling to comply with the requirements of the protocol.
Subject has previously entered this study.
Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
Subject suffers from claustrophobia.
Subject has impaired renal function (creatinine > 1.5 mg/dl).
Subject is in unstable condition.
ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms
Subject cannot safely be administered Lexiscan™ per prescribing information as determined by investigator
Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree between cardiac CTA, SPECT, and/or CT stress perfusion studies.

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Treatment-related Adverse Events

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.

Posted

Number

Adverse events

30 days +/- 3 days

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard Subject Enrollment	This study will plan to include 100 adults who present to the MUSC ED, hospital, or outpatient clinic with a clinical history and symptoms suspicious for cardiac ischemia and who have undergone or will likely undergo nuclear stress testing (SPECT). Patients who have been referred for a coronary CTA performed as part of a standard clinical evaluation determined by the treating physician(s) will be eligible for the study and recruited from the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist or primary physician will be contacted to ensure patient interest in the study and willingness to be approached. Willing patients will be approached and will undergo the informed consent process.

ID	Term
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis