Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting

This will be a prospective, observational study designed to include a convenience sample of
all qualifying patients undergoing myocardial CTP.

The study will enroll patients who have undergone a clinically indicated CCTA for suspicion
of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that
examination. CCTA is a clinically indicated and standard of care procedure at Lancaster
General Hospital. This pilot study will enroll a convenience sample of fifteen (15) patients
at Lancaster General Hospital who satisfy all study criteria.

When a patient has a coronary CTA, physician co-investigators, all of whom are certified by
the Certification Board of Cardiovascular Computed Tomography and credentialed by Johns
Hopkins for CTP, will evaluate the scan for the presence of lesions that would qualify the
patient for inclusion. Patients with lesions between 50% and 70% will be approached for
participation in the CTP study(37). Those who agree to participate will be scheduled to have
the CTP performed within thirty (30) days of the initial Coronary CTA procedure.

The CTP procedure involves infusion of a stress agent and a contrast bolus prior to image
acquisition. The CTP examination will be graded using the standard 17-segment myocardial
model recommended by the ACCF/AHA for nuclear myocardial perfusion and stress
echocardiography, in comparison to the myocardial appearance from the baseline coronary CTA.
Areas of myocardial hypo-enhancement (decreased CT signal) under hyperemic conditions
(coronary vasodilation during the regadenoson infusion) indicate possible ischemia.

If a coronary stenosis is severe enough to reduce myocardial perfusion, then studies have
shown that an invasive therapy that includes revascularization offers benefit to the patient.
Use of CTP may allow the investigators to determine, with improved accuracy, if patients have
hemodynamically significant coronary stenoses. These results will be reported to the
patients' treating physicians and may be used in treatment planning.

Inclusion Criteria:

- Index CCTA. The patient must have a CCTA done for clinical indications within the 2
weeks prior to consent/enrollment, ordered by The Heart Group of Lancaster General
Health.

- Age greater than 18 years.

- Lesion(s) requiring further testing. Upon review of the coronary CT angiogram, the
interpreting physician (who was trained at the Johns Hopkins course for CTP imaging)
finds at least one lesion that could benefit from further evaluation, specifically at
least one stenosis of 50%-70%, or lesions with unclear stenosis severity suspected of
being 50%-70%.

- Referring physician agreement. The referring physician has been contacted and agrees
that the patient can be approached for consent.

- Informed consent. The patient is willing and able to provide informed consent.

Exclusion Criteria:

- CCTA complication. After an observation period of at least 20 minutes after the index
CCTA, any evidence of MACE, allergy, or any other untoward clinical event that reduces
CTP safety or suitability (as defined by attending physician) will exclude a patient
from eligibility.

- Contraindication to regadenosen according to LGH protocol (addendum 2).

- Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in
the interim between CCTA and CTP. Electrocardiographic evidence of acute ischemia
includes acute STEMI (ST elevation equal to or greater than 1mm in two or more leads),
ST segment depression and/or T wave inversion (not known to be old and thought to be
evidence of ongoing ischemia). Positive cardiac biomarkers include elevated troponin,
myoglobin, and/or creatinine phosphokinase MB fraction).

- History of asthma or chronic obstructive pulmonary disease requiring bronchodilators
or steroid therapy within the past 3 months.

- Inability to tolerate beta blockers.

- Atrio-ventricular block (Type II-III), prolonged QT interval or sick sinus syndrome.

- Renal insufficiency (creatinine ≥1.6 and/or, GFR < 60 ml/m) or renal failure requiring
dialysis.

- Atrial fibrillation or other markedly irregular rhythm.

- Psychological unsuitability or extreme claustrophobia.

- Pregnancy or unknown pregnancy status.

- Clinical instability as deemed by the attending physician; including but not limited
to: cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory
hypertension (systolic blood pressure > 180 mmHg), sustained ventricular or atrial
arrhythmia requiring intravenous medications.

- Use of Viagra or Cialis in the past 24 hours.

- Known history of allergy or adverse reactions to x-ray dye, regadenoson or
aminophylline.

- Use of caffeine within the previous 12 hours (inactivates regadenoson).

- History of severe aortic stenosis.