Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 主要终点
- Qualitative Quality Comparison
研究概览
简要总结
Coronary computed tomography angiography (CCTA) is a frequently performed test for the diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected patients. The performance of non-contrast computed tomography for the detection and quantification of coronary calcification is typically performed prior to CCTA in an effort to identify significant calcification which may influence subsequent data acquisition during the CCTA. However, performance of calcium scoring adds significant radiation and most coronary calcification is proximal in its location, potentially visualized using a focused non-contrast scan.
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance.
详细描述
Prior to undergoing CCTA, non-contrast CT scanning of the entire heart is usually performed in adults over 50-years of age in order to assess for the presence and severity of coronary artery calcium. By providing a modified CT scan with a reduced length the same data can be obtained by the imager to ensure a high quality scan while decreasing the patient's overall radiation exposure. Our objectives and specific aims to validate our hypothesis include:
- To assess the impact on CCTA image quality using modified calcium score approach
- To determine the rate of changes in the coronary CT angiography acquisition parameters after evaluation of the modified versus standard calcium scoring scout series. Significant changes in CCTA acquisition include any of the following as compared to recommended CCTA parameters prior to scout CT performance: a change (increase or decrease) in tube current (mA) by 50, any change in tube potential (kV), change to/from retrospectively-gated CCTA, any change in padding (acquisition window), or changing to/from a high definition CT scan acquisition.
- To assess the difference in patient estimated effective radiation exposure (mSv) between the modified versus standard calcium scoring techniques.
- To assess the difference in patient estimated effective radiation exposure (mSv) of the entire CCTA study (plus calcium scoring) between groups.
Study Design Prospective, randomized single-center cohort study.
Anticipated Requirements
- Facilities: Walter Reed National Military Medical Center
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adult patients ≥ 50 years of age;
- •Suspected but without known prior history of CAD. Prior CAD is defined as a history of myocardial infarction, coronary revascularization or ≥ 50% coronary lumen stenosis on prior coronary angiography
- •Scheduled for non-emergent clinically indicated coronary CT angiography
排除标准
- •Prior coronary bypass graft (CABG) surgery
- •Suspicion of acute coronary syndrome (MI or unstable angina)
- •Known complex congenital heart disease
- •Evidence of ongoing or active clinical instability, including chest pain (sudden onset); cardiogenic shock; unstable blood pressure with systolic blood pressure < 90 mmHg; and severe congestive heart failure (NYHA class III or IV); or acute pulmonary embolism
- •Atrial fibrillation
- •Abnormal renal function (GFR < 60 ml/min; Creatinine > 1.5 mg/dL)
- •Concomitant participation in another clinical trial in which patient is subject to investigation drug or device
- •Pregnancy or unknown pregnancy status
- •Allergy to iodinated contrast agent
- •Contraindications to nitroglycerin
- •Unwilling or unable to give consent
- •Inability to comply with study procedures
- •Prior coronary artery calcium score and/or coronary CT angiogram
结局指标
主要结局
Qualitative Quality Comparison
时间窗: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale). 1. = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast. 2. = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis. 3. = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque. 4. = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
Quantitative Quality Comparison
时间窗: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio): image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.
次要结局
- Number of Patients With Coronary CT Using High Definition Scanning.(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Number of Participants for Which There Was a Scan Termination Event(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Comparison Radiation Exposure in Non-Con CT (Dose Length Product)(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Number of Patients With Coronary CT Parameter Changes (mA by 50).(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
- Number of Patients With Coronary CT Parameter Changes (Tube Potential).(Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).)
研究者
Hampton Crimm
Principal Investigator
Walter Reed National Military Medical Center