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临床试验/NCT01972009
NCT01972009Unknown不适用

Systematic Assessment of Pulmonary Artery Haemodynamics Using Wave Intensity Analysis

Imperial College London1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
Wave reflection coefficient

研究概览

简要总结

The mechanism governing how blood flows from the heart to the lungs depends on many factors including the pumping function of the right ventricle, properties of the arteries that carry the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs themselves.

Under normal conditions the pressure in the pulmonary arteries is well controlled and significantly lower than in the systemic circulation, however there are a number of conditions that lead to abnormally high pressures and significant morbidity and mortality.

However different patients respond differently to similarly elevated pressures, leading doctors to believe that there must be differences in either the right ventricles, the properties of the arteries, or the lungs themselves. It can be difficult to determine the relative contributions of each of these factors on blood flow because their effects are superimposed on each other.

One approach that has been used to look at this in other parts of the circulation (including in the systemic circulation and the coronary arteries) is to measure simultaneous pressure and flow, and apply a technique called wave intensity analysis (WIA). This technique can amongst other things, quantify the separate effects of wave reflection and the 'reservoir function' (or compliance) of the arteries, and in the systemic circulation WIA has increased the understanding of the mechanisms behind hypertension and the physiological changes of ageing. The pulmonary arteries are accepted to be very different from the systemic circulation and the mechanisms behind pulmonary hypertension are thought to be very different to those of systemic hypertension.

This protocol aims to determine the major influences on blood flow in the pulmonary arteries in health and disease, to help to understand why some patients are affected more than others by elevated pulmonary pressures.

详细描述

Purpose Currently best clinical practice for the investigation of pulmonary hypertension (raised pulmonary pressures) involves patients attending the catheter laboratory and catheters being passed under fluoroscopic guidance via the femoral vein to measure right heart pressures (and generally also via the femoral artery and aorta to measure left sided pressures). Wave intensity analysis using simultaneous pressure and flow measurements gives additional information about the upstream and downstream effects on haemodynamics, and we propose will lead to a more detailed assessment of the influences both causing and exacerbating pulmonary hypertension. Until recently it has not been possible to assess these effects formally: the standard technique measures only local pressure.

Design This protocol will involve passing catheters as per usual practice into the pulmonary arteries and aorta. A Combiwire (a standard pressure and flow measurement wire which has been available commercially and used worldwide for the past 5 years for making physiological measurements in the coronary arteries) will then be advanced approximately 1cm beyond the end of the catheter. Participants will have the usual clinical protocol of left and right heart catheterisation (and coronary angiography if clinically indicated) and the simultaneous pressure and flow measurements will be made in addition. Participants will also have noninvasive imaging (echocardiography and, if clinically indicated, cardiac MRI) and serum biochemical measures, as per usual clinical practice. They will also undergo cardiopulmonary exercise testing to assess their lung and cardiac capacity.

Recruitment The investigators will recruit patients with pulmonary hypertension from the National Pulmonary Hypertension Service who are awaiting right and left heart catheterisation studies as part of their routine diagnostic work up. Patients with normal pulmonary pressures will be recruited from patients who are on the waiting list awaiting routine cardiac catheterisation for the investigation of shortness of breath and chest pain. Recruitment will involve a discussion with the patient and printed material that the patient can refer to. They will be fully aware of the additional measurements being made, and no therapeutic promises will be made.

Development of Research Proposal Interventional cardiologists, pulmonary hypertension specialists, clinical scientists and basic scientists have been involved with the development of this protocol. All members have been involved in critiquing the proposal. The investigators have also consulted patients who have been involved in previous research conducted during angiography regarding the number of hospital visits and additional time required during the procedure for data collection.

Consent All patients will be consented for the study by the research Fellow who will be a Cardiology SpR (MBBS, MRCP) or Pulmonary Hypertension Specialist. She will be able to assess capacity and understand the ethical principles underpinning informed consent.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing right and left heart catheterisation.

排除标准

  • under 18 years of age
  • atrial fibrillation
  • chronic renal failure (eGFR <30)
  • unable to exercise
  • unable to consent
  • pulmonary embolism in the last 3 months

结局指标

主要结局

Wave reflection coefficient

时间窗: 6 months

次要结局

  • Reservoir function(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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