NCT05142215已完成不适用
ORBITA-CTO Pilot: A Comparison of the Impact of CTO PCI Versus Placebo on Angina in Patients With Background Optimal Medical Therapy - a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Change in angina symptom ordinal scale score between groups
研究概览
简要总结
ORBITA-CTO Pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ORBITA CTO will enrol patients who meet all 5 of the following criteria:
- •Accepted for CTO PCI procedure by a specialist CTO operator.
- •Patients with symptoms related to a single vessel CTO (≥3 months duration, or probable CTO where duration is unknown) in a vessel of at least 2.5mm diameter without angiographically significant (LMS ≥50%, LAD/Cx/RCA/Graft ≥70%, ≥2mm diameter) coronary artery stenosis in remaining non-CTO vessels.
- •Symptoms are:
- •a) Typical exertional angina defined as: i) constricting discomfort in the front of the chest or in the neck, jaw, shoulder or arm ii) precipitated by physical exertion iii) relieved by rest or nitrates within 5 minutes b) Angina symptoms at rest (including decubitus angina and post-prandial angina).
- •c) Shortness of breath on exertion considered to be angina equivalent.
- •Clinical evidence of ischaemia in CTO territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion CMR or PET).
- •Evidence of viability: If left ventricular angiogram or echocardiogram demonstrates LV impairment or RWMA then viability must be demonstrated.
- •J-CTO score ≤ 3.
排除标准
- •Acute coronary syndrome within 4 weeks.
- •PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI.
- •Non-revascularised clinically important non-CTO vessel.
- •Proven ischaemia (invasive or non-invasive) in non-culprit territory.
- •Contraindications to PCI or drug-eluting stent (DES) implantation.
- •Inability to tolerate or contraindication to DAPT.
- •Severe valvular heart disease.
- •Severe chronic pulmonary disease (FEV1 <30% of predicted value).
- •Severe musculoskeletal disease resulting in immobility.
- •Life expectancy <2years.
- •Age <18years.
- •Inability to consent.
结局指标
主要结局
Change in angina symptom ordinal scale score between groups
时间窗: 24 & 26 weeks
Change in angina symptom ordinal scale score between groups
次要结局
- Quality of life as measured by EQ-5D-5L(24 & 26 weeks)
- Change in peak VO2 and VO2 at AT(24 weeks)
- Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)(24 & 26 weeks)
- SAQ summary score(24 & 26 weeks)
- Change in Rose dyspnea scale(24 & 26 weeks)
- Fidelity of blinding using Bang's blinding index (BI)(24 weeks)
- Protocol adherence(26 weeks)
研究者
研究点 (5)
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