The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain

Stopped early

Conditions studied: Cardiology, Radiology, Stenoses

In brief

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 presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.

Key facts

Study ID

NCT03800862

Run by

Lancaster General Hospital

People needed

14

Starts

2019-03-27

Expected to finish

2022-10-27

Last updated by the study team

2022-12-27

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Penn Medicine / Lancaster General Hospital — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.