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临床试验/NCT03097172
NCT03097172已完成不适用

The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention

Mid and South Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Coronary physiology changes

研究概览

简要总结

This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries.

When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down.

The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.

详细描述

The study will contain two groups:

Group 1 - stable elective patients with stenotic coronary arteries. These patients are referred as outpatients for a 'pressure wire' test.

Group 2 - stable elective patients with a chronic total occlusion of an artery (CTO). The artery will be either the left anterior descending artery (LAD) or right coronary artery (RCA)

Group 1 - 30 patients

Patients will be recruited from referrals to the centre for a pressure wire study. Participants will be screened for eligibility using the protocol inclusion and exclusion criteria. Study information will be given and informed consent obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age > 18 years of age
  • Angina symptoms or evidence of myocardial ischaemia
  • Stenosis >50% in LAD or RCA on coronary angiogram or CT coronary angiogram
  • Participant is willing and able to give informed consent
  • Eligible for PCI

排除标准

  • Previous CABG with any patent grafts
  • Significant left main stem stenosis
  • Lesion of interest in Circumflex artery
  • Haemodynamic Instability
  • Unable to consent
  • Unable to receive dual antiplatelet therapy
  • Contraindication to adenosine
  • Recent acute coronary syndrome (ACS) (<48 hours)
  • Unable to lie prone
  • Severe valvular heart disease or cardiomyopathy
  • Inclusion Criteria:
  • Age >18 years of age
  • Stable angina / ischaemic symptoms / and / or
  • Evidence of viability and /or ischaemia in the chronic total occlusion (CTO) territory
  • Participant is willing and able to give informed consent.
  • Presence of chronic total occlusion (CTO) in LAD or RCA
  • Eligible for PCI to a chronic total occlusion (CTO)
  • Exclusion Criteria:
  • Previous CABG with any patent grafts
  • Significant left main stem stenosis
  • Dominant collateral supply from circumflex artery
  • Both LAD and RCA occluded
  • Haemodynamic instability
  • Unable to receive antiplatelet therapy
  • Contraindication to adenosine
  • Recent ACS (<48 hours)
  • Severe valvular heart disease or cardiomyopathy
  • Contraindication to Cardiac MRI
  • Unable to lie prone

结局指标

主要结局

Coronary physiology changes

时间窗: 5 minutes

Changes in coronary physiology in the same vessel when comparing prone and supine patient position

次要结局

  • MRI finding(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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