Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon-counting Detector Dual-source CT and Its Impact on Patient Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change in disease status or post-exam recommendations
研究概览
简要总结
The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) provide clinically important information about the severity of suspected coronary artery disease and perfusion defects compared to traditional Energy Integrating Detector CT (EID-CT) and nuclear medicine cardiac stress tests.
详细描述
This study will focus on demonstrating the benefits of PCD-CT for clinical indications and findings where the improved spatial and temporal resolution, decreased quantum and electronic noise, improved spectral imaging capabilities, and increased iodine signal are expected to benefit the diagnosis and characterization of CAD and myocardial perfusion defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
- •Patients who are able and willing to sign the informed consent will be enrolled
- •Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).
排除标准
- •Patients unable to provide written informed consent
- •Pregnancy
- •eGFR ≤ 30
- •History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
- •Any history of required premedication prior to iodinated contrast administration.
- •Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
- •Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities
- •Hospitalized patients or patients under care in the Emergency Department
- •Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):
- •Anything by mouth within three hours of the examination
- •Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
- •Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
- •Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
- •Ingested greater than 4 oz. of caffeine within the last 12 hours.
- •Currently experiencing unstable coronary syndrome.
- •Uncontrollable seizures within the last 3 months
研究组 & 干预措施
Clinical Coronary CTA Cohort
Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT.
干预措施: Photon-counting detector computed tomography (PCD-CT) (Diagnostic Test)
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort
Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent.
干预措施: Photon-counting detector computed tomography (PCD-CT) (Diagnostic Test)
结局指标
主要结局
Change in disease status or post-exam recommendations
时间窗: Through completion of CT exam, approximately 1 day
A sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will compare qualitative and quantitative results from the photon counting CT scans to the clinically ordered CT, MRI, or nuclear medicine scan. Clinically important differences in findings and recommendations will be recorded to assess the overall clinical impact of using photon-counting CT to assess patients with potential coronary artery disease, especially patients with heavily calcified, stented, or high-risk plaques, or having myocardial perfusion defects. Our premise is that the established benefits of PCD-CT, used with a dual-source geometry and advanced noise reduction and material decomposition algorithms, will yield clinically important differences in imaging findings that will impact patient management decisions.
Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis
时间窗: Through completion of CT exam, approximately 1 hour
Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update.
Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest
时间窗: Through completion of CT exam, approximately 1 hour
Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken when the patient was at rest.
次要结局
- Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score(Through completion of CT exam, approximately 1 hour)
- Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress(Through completion of CT exam, approximately 1 hour)
研究者
Cynthia McCollough
Principal Investigator
Mayo Clinic