Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Correlation between cCTA and OCT for MLA measurements
研究概览
简要总结
The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.
详细描述
Analysis of cCTA and OCT was conducted under blind in independent organizations.
After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.
After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.
Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.
排除标准
- •Prior coronary artery bypass graft (CABG) surgery
- •Contraindication to beta blocker agents or nitrates
- •Tachycardia or significant arrhythmia
- •Impaired chronic renal function (eGFR <30)
- •Subjects with known anaphylactic allergy to iodinated contrast material
- •Pregnancy or unknown pregnancy status in subject of childbearing potential
- •Cases with poor OCT or CCTA image for analyzing
结局指标
主要结局
Correlation between cCTA and OCT for MLA measurements
时间窗: Immediately after OCT scan
次要结局
- Correlation between FFRCT and FFROCT(Immediately after OCT scan)
- Impact of calcification on the agreement of MLA between OCT and cCTA measurement(Immediately after OCT scan)
- Impact of calcification on the agreement of FFR between OCT and cCTA(Immediately after OCT scan)
研究者
Hiromasa Otake
Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe University