NL-OMON20004尚未招募不适用
Improving the Cost-effectiveness Of Coronary Artery Disease Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,475
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •The subject is = 18 years of age
- •- The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up
- •- The subject has the clinical suspicion of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.
- •- The subject has undergone =64 multidetector row coronary CTA as part of usual care deemed by the treating physician, which shows a CAD-RADS score of 0-2
排除标准
- •- The subject is suffering from unstable angina pectoris.
- •- The subject is suffering from decompensated congestive cardiac failure.
- •- The subject is suffering from a known non-ischemic cardiomyopathy.
- •- The subject has a history of PCI or coronary artery bypass grafting (CABG).
- •- The subject has had pacemaker or internal defibrillator leads implanted.
- •- The subject has a prosthetic heart valve.
- •- There is a severe language barrier.
- •- The subject participates in any other clinical trial that interferes with the current study.
- •- Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.
- •- The subject is or might be pregnant.
- •- The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:
- •The subject is suffering from a cardiac rhythm other than sinus rhythm.
- •The subject is morbidly obese (Body Mass Index (BMI) > 40).
- •The subject is not able to sustain a breath-hold for 25 seconds.
- •The subject is unable to remain in supine position for at least 30 minutes.
- •The subject has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) < 45 ml/min/1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR < 60 ml/min/1,73m2.
研究者
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