跳至主要内容
临床试验/NCT03800862
NCT03800862终止不适用

The Role of Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) and Myocardial Computed Tomographic Perfusion (CTP) in Patients Presenting With Chest Discomfort

Lancaster General Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
1
主要终点
Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain.

研究概览

简要总结

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.

详细描述

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 of over 90% 1-4. Patients with normal CCTA findings have an excellent prognosis and do not require further testing for CAD 5. However, like invasive coronary angiography (CATH), CCTA is an anatomic test and, cannot reliably predict the impairment of flow (functional significance) of Coronary stenoses.

For this reason, in approximately 15-25% of patients, additional functional testing may be required after CCTA, usually in the form of stress testing 6-8. Stress testing is commonly done by exercise or pharmacologic stress with electrocardiographic monitoring and often, imaging of myocardial perfusion by nuclear scintigraphy (MPI) or detection of abnormal contraction by echocardiography. Furthermore, in patients with previously known CAD, CCTA alone is not an adequate test, because in most cases there are multiple lesions that are possible sources of ischemia. Over the last two decades the number of abnormal stress studies have decreased substantially from 40.9% in 1991 to 8.7% in 20099. This underscores the need for an accurate mechanism to identify which patients best benefit from invasive angiography.

Myocardial Computed Tomographic Perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) have emerged as promising ways to identify ischemia when there is coronary disease identified by CCTA. The two tests provide different and perhaps complimentary information. Fractional Flow Reserve (FFR) measures the difference in flow created by a coronary stenosis before and after the administration of a vasodilator agent by measuring the drop in pressure across the stenosis. Coronary Flow Reserve (CFR) measures flow at maximum vasodilation versus flow at rest in a given arterial tree.

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% 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.

The CT scanner to be used for this study is an Aquilion ONE ViSION edition 320-detector row scanner with 0.5-mm nominal width detector elements (Toshiba Medical Systems, Otawara, Japan). The scanner has a minimum rotation time of 275 ms. The CT acquisition software includes a novel dose reduction technology (Adaptive Iterative Dose Reduction 3D (AIDR 3D) Toshiba Medical Systems, Otawara, Japan).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • 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.

结局指标

主要结局

Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain.

时间窗: Day of imaging (processing of CT-FFR images and reading of CTP images expected to be performed within 48 hours of imaging)

Performance of CT-FFR compared to CTP for each vessel assessed, as per the below common suite of measures: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, discrimination

次要结局

  • Cardiac Long Term Outcomes(MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging)
  • Outcome agreement CTP and CT-FFR (when CT-FFR values are <.80 and >0.80(MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging)
  • Compare measures of CTP and CT-FFR with Coronary Angiography and invasive FFR (in cases where clinically indicated)(MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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