The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Incidence of Venous Thrombo-Embolism (VTE)
研究概览
简要总结
A prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (CTPA) protocol for suspected pulmonary embolism in pregnancy
详细描述
The OPTICA study is the first prospective study of a low-dose CTPA protocol for the pregnant population. It will define the achievable dose, image quality and safety of this protocol and provide an evidence base upon which modern CTPA protocols can be appropriately compared to scintigraphy for this population.
Pregnant women undergoing the specified low-dose CTPA protocol for suspected pulmonary embolism (PE), agreed across study sites with equivalent computed-tomography (CT) capabilities, will be included. Independent review of CTPAs by two radiology consultants, image data analysis and 3-month patient follow up will be performed.
The diagnostic algorithm employs chest-x-ray and lower limb Doppler if lower limb symptoms are present, followed by CTPA in cases where advanced imaging is required. D-dimer is permitted within the diagnostic algorithm for patients recruited after implementation of the updated 2019 "European Society of Cardiology guidelines for diagnosis and management of acute pulmonary embolism".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients with a suspected pulmonary embolism
- •Age≥18 years
排除标准
- •Age < 18 years
- •Ultrasound proof of symptomatic proximal deep vein thrombosis
- •Contraindication to helical CT because of allergy to intravenous iodinated contrast or renal insufficiency (creatinine clearance <30 ml/min)
- •Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin initiated 24 h or more prior to eligibility assessment
- •Treatment with vitamin K antagonists (coumarin derivates i.e. warfarin)
- •Unable or unwilling to consent
- •Unable to part-take in follow-up
- •Life expectancy <3 months
结局指标
主要结局
Incidence of Venous Thrombo-Embolism (VTE)
时间窗: 3 months
3-month incidence of venous thromboembolism in pregnant patients in whom pulmonary embolism was excluded at baseline CT pulmonary angiogram.
次要结局
- Maternal Effective Dose(3 months)
- Breast Radiation Dose(3 months)
- Foetal Radiation Dose(3 months)
- Signal to Noise Ratio(3 months)
- Contrast to Noise Ratio(3 months)
- Mean Pulmonary Trunk Enhancement(3 months)
- Subjective Imaging Quality Grade(3 months)
研究者
Peter MacMahon
Professor Peter J Mac Mahon, MB BCH BAO, BMedSci, MRCPI, FFRRCSI.
Mater Misericordiae University Hospital