Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Condition: Cardiovascular Diseases; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease
Intervention: Lexiscan
Intervention description: Coronary vasodilator
Intervention MeSH terms: Regadenoson
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Computed Tomography

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.
    

Eligibility criteria:

        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.