Back to resultsUse of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Primary Purpose
Cardiovascular Diseases, Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lexiscan
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiovascular Diseases focused on measuring Computed Tomography
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Myocardial Stress CT Perfusion
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment
Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Full Information
NCT ID
NCT03103061
First Posted
March 28, 2017
Last Updated
July 18, 2019
Sponsor
Medical University of South Carolina
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03103061
Brief Title
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Official Title
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Astellas Pharma US, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of 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. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Artery Disease
Keywords
Computed Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myocardial Stress CT Perfusion
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lexiscan
Intervention Description
Coronary vasodilator
Primary Outcome Measure Information:
Title
Number of Treatment-related Adverse Events
Description
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.
Time Frame
30 days +/- 3 days
Secondary Outcome Measure Information:
Title
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment
Description
Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Time Frame
Immediately following CT perfusion imaging.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
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