Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Proportion of patients completing the DW-MRI test
研究概览
简要总结
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
详细描述
There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations.
Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 years and above;
- •referred for an elective, non-cardiac, non-vascular and non-brain surgery;
- •with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.
排除标准
- •patients in need for long-term, perioperative anticoagulants;
- •those with comorbidities that potentially increase the risk of perioperative stroke;
- •contraindications to MRI;
- •unable to complete or adhere to the study.
结局指标
主要结局
Proportion of patients completing the DW-MRI test
时间窗: 2-7 days post surgery
Developing mechanisms to successfully arrange the DW-MRI within a short timeframe
Prevalence of PFO in the target (surgical) population
时间窗: Pre-operative
Identifying PFO status using TCD \& TTE
The incidence of perioperative stroke in patients without PFO
时间窗: Within 30 days of surgery
Identifying perioperative stroke incidence using DW-MRI
Study enrollment rate
时间窗: Pre-operative
Establishing study enrollment rate and the reasons for refusals to participate
次要结局
未报告次要终点
研究者
Eric Horlick
Director, Structural Heart Disease
University Health Network, Toronto