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



Status:Completed
Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:7/20/2018
Start Date:February 9, 2016
End Date:June 14, 2018

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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.


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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: U. Joseph Schoepf, MD
Phone: 843-876-4922
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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mi
from
Charleston, SC
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