Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
研究概览
简要总结
A single site cross-sectional comparison of paired diagnostic imaging modalities.
This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.
详细描述
This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.
Collected data will be analysed regarding two novel hypothesised methods of using CEUS information:
The first is recording temporal delay between contrast in graft and contrast in endoleak to define endoleak type. Potentially this could be used as a faster method of defining endoleak type in a surveillance programme.
The second is to identify/refute correlation between CEUS contrast to appear in endoleak vs tCTA contrast to appear in endoleak. If an association can be established, CEUS timings could potentially then be used to time 'standard' CTA phases to improve CTAs diagnostic accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over
- •Able to give informed consent
- •Undergone an EVAR of infra-renal abdominal aortic aneurysm
- •Planned for CTA of EVAR
排除标准
- •Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR <45) Overactive thyroid gland
- •Unable to receive CEUS contrast Previous reaction to Sonovue (Ultrasound Contrast) Allergy to sulphur hexafluoride (used in electrical industry in circuit breakers, switch gears & electrical equipment) Recent acute coronary syndrome or unstable angina, typical angina at rest or frequent or repeated angina/chest pain - all within previous 7 days Recent coronary intervention
- •Previous embolization of artery in region of EVAR (affects imaging quality)
- •BMI >30 (affects imaging quality)
结局指标
主要结局
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
时间窗: Immediate
Will be presented as a Sensitivity \& specificity
次要结局
- Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention(Immediate)
- Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression.(Immediate)
- Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA.(Immediate)
- Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.(Immediate)
- Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention(6 months)
- Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA(Immediate)