Status:
TERMINATED
The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain
Lead Sponsor:
Lancaster General Hospital
Conditions:
Cardiology
Radiology
Eligibility:
All Genders
45-85 years
Brief Summary
This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients pr...
Detailed Description
Coronary artery computed tomographic angiography (CCTA) is a widely used, highly accurate technique for the detection of coronary artery disease (CAD), with sensitivity and negative predictive values ...
Eligibility Criteria
Inclusion
- Age 45 - 85 years.
- Clinically indicated coronary CTA with one or more lesions greater than 50% in the epicardial vessels.
- Referring physician agreement to approach the patient for consent.
- Informed consent from the patient or authorized representative.
- Scheduled CTA for CT-FFR and CTP within 60 days of the clinically indicated CCTA and prior to any indicated coronary angiography.
- \-
Exclusion
- 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.
- Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in the interim between index CCTA and CTA for CT-FFR 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).
- 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, Glomerular Filtration Rate (GFR) \< 60 ml/m) or renal failure requiring dialysis
- Atrial fibrillation or other markedly irregular rhythm.
- Psychological unsuitability or extreme claustrophobia.
- BMI \> 35.
- 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.
- Left main disease greater than 50% and occluded vessels (CAD RADS 5) identified by index Coronary CTA
- Left Ventricular Ejection Fraction (LVEF) of less than 30%.
- Significant radiation exposure in the past 18 months (\>5 rems OR 2 nuclear or CT studies)
- Contraindication to CT-FFR: History of myocardial infarction (MI), chronic total occlusions (CTO), stent insertion or PCI, coronary artery bypass grafting (CABG), or arrhythmias; presence of anomalous coronary arteries, anomalous origins of the coronary arteries, or a single coronary artery.
- \-
Key Trial Info
Start Date :
March 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03800862
Start Date
March 27 2019
End Date
October 27 2022
Last Update
December 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn Medicine / Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602