Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
Computed Tomography
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.
Interventions
DRUGLexiscan
Coronary vasodilator
Sponsors
Astellas Pharma US, Inc.
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician. 2. 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. 3. Subject must be 18 - 85 years of age. 4. Subject must provide written informed consent prior to any study-related procedures being performed. 5. Subject must be willing to comply with all clinical study procedures.
Exclusion criteria
1. 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. 2. Subject has severe asthma or COPD requiring frequent inhaler use. 3. Subject has prior diagnosis of obstructive CAD that has not been revascularized. 4. Subject with implanted rhythm devices (pacemaker, defibrillator). 5. Subject has significant arrhythmia. 6. Subject has high grade heart block. 7. Subject has resting heart rate \< 45 bpm, systolic blood pressure \<90 mm Hg, or has consumed caffeine within the last 12 hours. 8. Subject has an acute psychiatric disorder. 9. Subject is unwilling to comply with the requirements of the protocol. 10. Subject has previously entered this study. 11. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study. 12. Subject suffers from claustrophobia. 13. Subject has impaired renal function (creatinine \> 1.5 mg/dl). 14. Subject is in unstable condition. 15. ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms 16. Subject cannot safely be administered Lexiscan™ per prescribing information as determined by investigator 17. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-related Adverse Events | 30 days +/- 3 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment | Immediately following CT perfusion imaging. | Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Standard Subject Enrollment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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.
Time frame: 30 days +/- 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Subject Enrollment | Number of Treatment-related Adverse Events | 6 Adverse events |
Secondary
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment
Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Time frame: Immediately following CT perfusion imaging.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Subject Enrollment | Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment | Sensitivity | 85.7 Percent |
| Standard Subject Enrollment | Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment | Specificity | 70.6 Percent |
| Standard Subject Enrollment | Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment | Accuracy | 75 Percent |