COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of extrinsic compression of the LMCA
研究概览
简要总结
The prevalence of critical ab extrinsic compression of left main coronary artery (LMCA) is very high in patients with pulmonary arterial hypertension (PAH) symptomatic for angina (up to 40% according to a recent study of 121 patients with PAH). The element that most of all correlates with the degree of coronary stenosis is the diameter of the pulmonary artery (PA). In particular, a diameter ≥ 40 mm has a sensitivity of 83% and a specificity of 70% in patients with angina. Critical stenosis of LMCA is a risk factor for sudden death and in these condition percutaneous coronary angioplasty with stent implantation has proven to be a safe and effective long-term procedure. Preliminary data from a retrospective analysis of the registry of patients with PAH in Bologna (ARCA registry, 109/2016/U/Oss) highlights that even in PAH patients asymptomatic for angina, compression of LMCA can occur in up to 13% of patients and the main predictive parameter of compression was found to be a diameter ≥ 42 mm (with a sensitivity of 87% and a specificity of 77%). Performing a screening test by coronary-CT scan in all subjects suffering of PAH with a PA diameter ≥ 40 mm even if asymptomatic for angina could therefore help to identify patients with PAH at increased risk for sudden death at an early stage.
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
- •Patients with PAH (group 1 of World Health Organization pulmonary hypertension classification) who have undergone at least one pulmonary CT angiography with a PA trunk diameter ≥ 4 cm
- •Age ≥18 years
- •Asymptomaticity for angina pectoris or anginal equivalent
排除标准
- •Severe chronic kidney disease [Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate <30 ml/min) or need for dialysis
- •Major allergy to iodinated contrast agent
- •Intolerance or allergy to acetylsalicylic acid or clopidogrel
- •History of stroke or transient ischemic attack in the last 6 months or a history of intracranial haemorrhage
- •Known cerebral arteriovenous malformation or aneurysm
- •Known moderate or severe hepatic insufficiency (Child Pugh B or C)
- •Thrombocytopenia (<100.000/μL) or anemia (hemoglobin <10 g/dL)
- •Active bleeding or factors which, in the investigator's judgment, significantly increase the risk of bleeding
- •Major surgery in the past 30 days
- •Cancer in the active phase
- •Pregnancy or breastfeeding
- •Patient prognosis <1 year in the opinion of the investigator
- •Any condition that increases the risk of non-compliance or of being lost to follow-up
- •Patients who have already undergone a LMCA angioplasty
- •Failure to obtain informed consent
结局指标
主要结局
Incidence of extrinsic compression of the LMCA
时间窗: Baseline
To evaluate the incidence of extrinsic compression of the LMCA in patients with PAH and a PA diameter of at least 4 cm, asymptomatic for angina pectoris, subjected to a screening test by coronary CT angiography
次要结局
- Incidence of extrinsic compression of the LMCA by radiological pattern(Baseline)
- Number of participants undergoing LMCA angioplasty with in-hospital complications(Baseline, 1 year)
- Six minute walking test (6MWT)(Baseline, 6 months)