Clinical trial NCT02756234: Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
Official title: Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
Collaborators: name: Toshiba America Medical Systems, Inc.
name: Astellas Pharma Inc
First posted: 2016-04-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The objective of this study is to carefully monitor all patients undergoing Computed Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the efficiency of the CTP procedure in a community setting.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as a result of CTP procedure.
timeFrame: Through study completion, expected 1 year.
Secondary outcomes:
measure: Number of days for a subject to be scheduled and complete CTP procedure post CCTA procedure.
timeFrame: 30 days
measure: Number of minutes it takes for CTP procedure to be completed on a subject. to complete a CTP procedure.
timeFrame: 90 minutes
measure: Number of minutes for a Provider to review and interpret CTP data and report out on CTP procedure.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Heatlh / Penn Medicine
state: Pennsylvania
Study officials:
affiliation: Lancaster General Health / Penn Medicine
name: Ron Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References:
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