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临床试验/NCT06543641
NCT06543641已完成不适用

Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography

Lauri Mansikkaniemi2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Stent patency assesment with third-generation dual-source CCTA

研究概览

简要总结

The goal of this clinical trial is to assess third-generation dual-source coronary computed tomography angiography (CCTA) performance in the evaluation of long coronary stents in patients with coronary artery chronic total occlusions. The main questions it aims to answer are:

  • Can patency of long coronary artery stents be assessed with third generation CCTA?
  • What are the factors affecting the assessability?
  • What is the radiation exposure of third generation CCTA?

详细描述

This prospective study complied with the Declaration of Helsinki and was approved by the ethics committee of Helsinki University Central Hospital. All patients gave a written informed consent prior to the beginning of the study.

Patient selection A registry that included chronic total occlusion (CTO) patients with stable coronary artery disease treated for CTO with percutaneous coronary angioplasty (CTO PCI) in Helsinki University Central Hospital starting from 2014 was used for this study. The study population included consecutive, prospectively recruited patients from 2014 to 2019. All patients meeting the study criteria were included in the study.

Definition Segments 5 mm proximal and 5 mm distal to the stent were considered as part of the stent for in-stent restenosis (ISR) evaluation, as proposed by the Academic Research Consortium and were included in CCTA performance analyses. Long CTO stents consisted of one or more coronary artery stents with possible combination of different stent types. The combined stent length was reported without possible overlap for multiple stents. The diameter of the largest stent or post-dilation balloon was reported. Based on previous CT studies and guidelines radiological ISR in CCTA was defined as luminal narrowing of ≥ 50% in the long CTO stent. CCTA result was considered negative if ISR was ruled out and positive if ISR was detected or if the result was inconclusive. Therefore, two groups defined by the CCTA result were formed. In patient-based analyses patients with two long CTO stents of which at least one was a CCTA positive stent were considered as CCTA positive. In native coronary arteries less than 25% was considered minimal, 25-49% mild, 50-69% moderate and 70-99% severe stenosis and 100% as an occlusion. Assessment of stenosis was based on direct visualisation. The study's experienced cardiac radiologist with over 15 years of experience was blinded for symptomatic data, stent type and stent quantity. The target vessel of implanted coronary artery stents was provided.

All patients underwent third-generation dual-source CCTA. In CCTA a non-contrast calcium score using standard 120 kilovolt (kV) acquisition and 3 mm slice thickness was obtained. Stented segments were manually subtracted from the score. Second, third-generation dual-source CCTA (Somatom Force, Siemens) was performed. Prospective ECG-triggering was applied regular heart rate < 70/min and/or in the case of previous stent implantation of right coronary artery (RCA) to avoid motion artefacts and FLASH- mode if the heart rate was regular and < 60/min. If the presenting heart rate was > 70/min, metoprolol 5-15 mg was administered intravenously. For patients with higher heart rates (> 70/min) prospective ECG-gating and widening of the acquisition window (padding) were used. Sublingual nitroglycerin was administered before scanning. A tube voltage of 100 kV, rotation time of 0.25 s, temporal resolution of 66 ms, collimation of 2 x 192 x 0.6 mm and pitch of 3.2 were used. Approximately 50 ml of contrast medium containing 350 mg/ml of iodine (Omnipaque 350, GE Healthcare) was injected intravenously at a flow rate of 5-5.7 ml/s, followed by a 47 ml saline solute. Axial images were reconstructed with 0.6 mm slice and evaluated using multiplanar reformation. Bv40 kernel, Advanced Modeled Iterative Reconstruction 3 (ADMIRE 3) and Iterative metal artefact reduction (iMAR) were utilised.

Clinical information and CCTA results were assessed by the interventional cardiologists and the following patients were offered invasive coronary angiography (ICA):

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

The study's cardiac radiologist was blinded for symptomatic data, stent type and stent quantity. The target vessel of implanted coronary artery stents was provided.

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surviving patients with a CTO PCI minimum of four years prior to the study date
  • Successful CTO PCI with a drug-eluting stent
  • Primary procedure minimum of four years prior to study date
  • CTO stent length ≥ 38 mm in right coronary artery (RCA) and left anterior descending (LAD) coronary artery
  • CTO stent length ≥ 30 mm in left circumflex coronary artery (LCX). The definition is clinical.
  • Age at primary procedure ≤ 75 years
  • Communication in English, Finnish or Swedish

排除标准

  • Malignancy with poor prognosis or ongoing diagnostics
  • Significantly impaired performance in daily activities
  • Significant psychiatric disorder
  • Active alcohol or drug abuse
  • Memory disorder or other cognitive impairment
  • Primary procedure in-stent CTO PCI
  • Target vessel revascularisation or CABG after the primary - procedure
  • Glomerular filtration rate ≤40 ml/min
  • ICA or CCTA less than six months prior to the study date

结局指标

主要结局

Stent patency assesment with third-generation dual-source CCTA

时间窗: up to 7.3 months (maximum time between CCTA and ICA)

Assessability of stent patency with third-generation dual-source CCTA in long coronary artery chronic total occlusion stents. CCTA results were divided into three categories: 1) negative (\<50% stent luminal narrowing), 2) ISR (\> 50% stent luminal narrowing) or 3) inconclusive (CCTA was not able to define the degree of stent luminal narrowing). Patients with ISR or inconclusive result were considered as CCTA positive. Confirmation imaging was conducted with ICA, if necessary. Positive predictive value, negative predictive value, sensitivity and specificity were calculated.

次要结局

  • To compare radiation exposure of third-generation dual-source CCTA to ICA, measured as effective dose, in patients receiving both examinations.(from CCTA to possible ICA, up two 7.3 months)
  • To determine significant differences in distribution of patient- and lesion-related characteristics in third-generation dual-source CCTA negative versus positive patient groups.(through study completion, average of 1 year)

研究者

发起方
Lauri Mansikkaniemi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lauri Mansikkaniemi

M.D.

Helsinki University Central Hospital

研究点 (2)

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