A Prospective, Randomized, Controlled, Parallel-group, Multicentre Trial to Examine the Cost-effectiveness and Safety of Adding the CADScorSystem as a Rule-out Test in Patients Referred With Symptoms Suggestive of Stable Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,016
- 试验地点
- 6
- 主要终点
- Cumulative number of non-invasive and invasive diagnostic procedures
研究概览
简要总结
This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.
详细描述
Purpose and Rationale for the Study:
The declining incidence of obstructive CAD and a good prognosis for patients with stable angina challenges the resource demanding approach recommended in current guidelines. The CADScor®System may be an efficient, fast and low-cost diagnostic tool with a high rule-out efficiency. The current study aims to investigate if the CADScor®System can be added as a rule-out test in patients referred with suspected stable CAD to reduce unnecessary testing
Study Hypothesis:
A Diamond-Forrester score plus CAD-score guided rule-out strategy is superior to a Diamond-Forrester score guided strategy alone in reducing diagnostic procedures and non-inferior in terms of safety outcomes in patients with symptoms suggestive of stable coronary artery disease.
Study Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation will be hidden from the independent Clinical Events Committee.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed the informed consent form.
- •Males and females, aged 30 years or above.
- •Be able and willing to comply with the clinical investigational plan.
- •Symptoms suggestive of stable coronary artery disease.
- •No history of coronary artery disease (prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
排除标准
- •Diamond-Forrester score >85%.
- •Prior non-invasive testing for stable CAD or invasive coronary angiography within 6 months of randomization.
- •Implanted donor heart, mechanical heart, mechanical heart pump.
- •Pacemaker or Cardioverter Defibrillator (ICD).
- •Implanted electronic equipment in the area above and around the heart.
- •Significant operation scars, abnormal body shape, fragile or compromised skin in the fourth left intercostal space recording area.
- •Receiving same day treatment with nitro-glycerine on the day of randomization.
- •The exclusion criteria '
- •Diamond-Forrester score >85%' was removed after updating the study according to the 2019 ESC guidelines on chronic coronary syndrome. According to these current guidelines, no patients should be referred to invasive diagnostic test based on their PTP alone, and therefore is this exclusion criteria is no longer relevant.
研究组 & 干预措施
Control group
The control group will receive standard-of-care treatment recommended by current ESC guidelines for patients with low to intermediate likelihood of stable CAD using the Diamond-Forrester (DF) score only: Rule-out if DF-score <15%; NIT if DF-score 15-85%.
As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome:
The control group will receive standard-of-care treatment recommended by current ESC guidelines based on the patients likelihood of stable CAD using the Pre-test Probability score (PTP): Rule-out if PTP≤5%, NIT may be considered if PTP 6-15%, NIT if PTP>15%
Intervention group
The intervention group will undergo a modified diagnostic pathway where a CAD-score <30 rules out stable CAD in the group of patients having a DF-score <15% and a CAD-score ≤20 rules out stable CAD in the group of patients having a DF-score in the range 15-85%, and thus not tested with NIT. Otherwise NIT is performed.
As per January 2020 the protocol was updated according to the 2019 ESC Guidelines on Chronic Coronary Syndrome:
The intervention group will undergo a modified diagnostic pathway where a CAD-score ≤20 rules out stable CAD. If CAD-score >20 NIT is performed.
干预措施: CADScor®System (Device)
结局指标
主要结局
Cumulative number of non-invasive and invasive diagnostic procedures
时间窗: 1 year
Difference between the two treatment groups in cumulative number of non-invasive and invasive diagnostic procedures. Non-invasive procedures include exercise electrocardiogram (ECG), cardiac computed tomography angiography (CCTA), Rubidium cardiac PET (Rb-PET), myocardial perfusion imaging (MPI), cardiac magnetic resonance imaging (CMRi) and stress echocardiography. Invasive procedures include invasive coronary angiography (ICA) only.
次要结局
- Incidence of Major adverse cardiac events (MACE)(1 year)
研究者
Eva Prescott
Professor
University Hospital Bispebjerg and Frederiksberg