Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of patients enrolled in the study of all those that are eligible
研究概览
简要总结
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of < 1.0cm2)
- •Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)
- •Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon)
排除标准
- •Severe renal dysfunction Glomerular filtration rate < 30 ml/min.
- •Severe left ventricular dysfunction LVEF ≤ 30%
- •Recent coronary angiography ≤ 6months from randomization
- •Recent PCI ≤ 6months from randomization
- •Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
研究组 & 干预措施
Selective invasive angiography based on CT/CCTA imaging
Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease.
干预措施: Selective invasive angiography based on CT/CCTA imaging. (Procedure)
Invasive Cardiac Angiography
Patients will undergo systematic invasive angiography.
干预措施: Procedure/Surgery: Invasive angiography (Procedure)
结局指标
主要结局
Number of patients enrolled in the study of all those that are eligible
时间窗: 18 months
This is the primary outcome for this pilot study to assess feasibility of a larger trial.
次要结局
- All-cause mortality(90 days)
- Myocardial Infarction(Peri-procedural (≤72h post procedure) and 90 days)
- Unplanned revascularization(90 days)
- Bleeding complication(Peri-procedural (≤72h post procedure) and 90 days)
- Device success(90 days)
- Acute Kidney Injury(90 days)
- Stroke(90 days)