Evaluation of the Ability of CTFFR to Determine Non-significant Lesions of Coronary Disease Based on MACE in One-year Follow-up of Patients (Seeing Beyond the Stenosis: CTFFR and MACE in a One-Year Follow-Up)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of patients with MACE
研究概览
简要总结
In this prospective cohort study, 250 patients with suspected or known CAD and at least one intermediate coronary lesion (50-70% stenosis) who had a NiFFR value greater than 0.80 underwent coronary computed tomography angiography (CCTA) with NiFFR assessment. Patients were followed for one year to monitor for MACE
详细描述
This prospective cohort includes people with known or suspected CAD who had both CCTA and ICA with this index (FFR) measurements. Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing.
Data about the patients was acquired from the Professor Kojuri registry. The database provided demographic information for instance age, gender, CAD family history, prior CAD history, hypertension (HTN), diabetes mellitus (DM), and hyperlipidaemia (HLP). The prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics were also collected from registry.
The target vessel was identified (LAD, RCA, LCX, or LMC), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. Measurements were taken using CCTA datasets using semi-automated software methods.
Patients were clinically monitored for one year after examination. The primary outcome was the occurrence of major cardiovascular consequences, or MACE, which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons. Throughout the one-year study period, all participants were visited every three months and followed up with phone calls.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing
排除标准
- •Patients having past coronary artery bypass graft surgery (CABG)
- •previous PCI in the target vascular
- •significant renal impairment define with eGFR < 30 mL/min/1.73 m²
- •contrast allergy
- •poor image quality that prevented appropriate CCTA or CT-FFR analysis
结局指标
主要结局
Number of patients with MACE
时间窗: 1 year
Number of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke
Number of patients with bleeding
时间窗: 1 year
Number of patients with major or minor bleeding based on BARC classification
次要结局
- Number of patients with dyspnoea(1 year)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences
