NCT02973126Unknown3 期
Assessment of Fractional Flow reservE Computed Tomography Versus Single Photon Emission Computed Tomography in the Diagnosis of Hemodynamically Significant Coronary Artery Disease. (AFFECTS)
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Positive finding of hemodynamically significant CAD according to FFRct.
研究概览
简要总结
The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in identifying vessel-specific, hemodynamically significant CAD in patients scheduled for invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In particular, the study will evaluate the ability of FFRct to correctly rule out hemodynamically significant CAD in patients with non-significant CAD or normal coronary arteries who had positive SPECT scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years
- •Providing written informed consent
- •Subjects with abnormal SPECT myocardial perfusion imaging results who have been referred for clinically indicated ICA within 90-days of SPECT.
- •Ability to undergo cCTA
排除标准
- •Acute coronary syndrome (ACS).
- •Prior, clinically documented, myocardial infarction (MI).
- •Prior coronary artery bypass grafting (CABG)
- •Prior coronary stenting
- •Evidence of ongoing or active clinical instability including unstable angina, intractable arrhythmia, cardiogenic shock, unstable BP, and severe CHF (NYHA class III or IV) or acute pulmonary edema
- •Contraindications for cCTA such as:
- •Presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired
- •Chronic atrial fibrillation with uncontrolled ventricular response
- •Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated
- •Pregnancy or unknown pregnancy status in women of childbearing age
- •Contraindication to acute beta blockade
- •Contraindication to acute sublingual nitrate administration
- •Prosthetic heart valve such that coronary visualization is impaired
- •Contraindications for FFRct such as:
- •Complex congenital heart disease other than anomalous coronary origins alone
- •Ventricular septal defect with known Qp/Qs > 1.4
- •Requiring an emergent procedure within 48 hours of presentation
- •Any active, serious, life-threatening disease with life expectancy less than 2 months
- •Inability to comply with study procedures
- •Current participation in any other clinical trial involving an investigational device, drug, or dictating care pathways at the time of enrollment
结局指标
主要结局
Positive finding of hemodynamically significant CAD according to FFRct.
时间窗: 24 months
Positive finding of hemodynamically significant CAD according to SPECT.
时间窗: 24 months
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
时间窗: 24 months
次要结局
- Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.(24 months)
- Cumulative radiation exposure in the study cohort during SPECT, cCTA, and ICA and potential impact of FFRct in reducing radiation exposure in patients with no hemodynamically significant CAD.(24 months)
- Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.(24 months)
研究者
研究点 (2)
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