Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Time to Composite of Major Adverse Cardiac Event (MACE)
研究概览
简要总结
- The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
- Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
- This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.
详细描述
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participants
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eligible participants are randomly assigned to systemic strategy or selective strategy
- participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test
- subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia
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participants who are not willing to be randomized will be included in the registration group
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revascularization
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a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed
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the duration from revascularization to PTA should be within 60 days
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percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
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blood sampling, genotyping, and measurement of biomarkers and microRNA
a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells 4. outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA
排除标准
- •Known CAD or unstable angina within past 3 months
- •Acute myocardial infarction within past 6 months
- •Known CAD status posterior percutaneous coronary intervention or bypass surgery within past 6 months
- •Planning to do bypass surgery for known LEAD\
- •Pregnancy
- •Documented active malignancy
- •Needing emergency PTA
结局指标
主要结局
Time to Composite of Major Adverse Cardiac Event (MACE)
时间窗: up to 48 months
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
次要结局
- MACE between the Screening and 30 days after PTA(30 days after indexed PTA)
- Time to Composite of major coronary events(Up to 48 months)
研究者
Ting-Hsing Chao
Associate Professor and Attending Physician
National Cheng-Kung University Hospital