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临床试验/NCT03729492
NCT03729492Unknown不适用

Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism

University of Aarhus0 个研究点目标入组 100 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Prevalence of CTED

研究概览

简要总结

Aim: To investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach.

Background: A number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated pulmonary arterial pressure at rest (CTED). However, current guidelines for follow-up after acute pulmonary embolism will miss all patients with CTED, as referral for further examination is based on elevated pulmonary arterial pressure on echocardiography. Thus, the prevalence of CTED is unknown. The hypothesis is, that a symptom-driven referral of patients with previous acute pulmonary embolism is more sensitive in diagnosing CTED than the current approach.

Methods and materials: Patients diagnosed with acute pulmonary embolism in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent pulmonary embolism related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a scintigraphy. If CTED is suspected from the scintigraphy, the patient will be referred for full CTED work-up. The investigators expect to screen 300 patients for persistent symptoms with an expected study time of 3 years.

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 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute PE diagnosed by CT or V/Q-scan within the last year.
  • Non-recovery or persistent PE related symptoms assessed by a MRC breathlessness score or WHO functional class.
  • Age >= 18 and < 80

排除标准

  • Contraindications or unable to perform 6 minutes walk distance (6MWD) and/or cardiopulmonary exercise test.
  • Contraindications to CT pulmonary angiography.
  • Congestive heart failure (LVEF <40%).
  • COPD or restrictive lung disease, severe or worse (FEV1 <50% and >=1 exacerbation causing hospital admission per year (GOLD grade 3 and 4 class C and D)).
  • Lactating or pregnant.
  • Unable or unwilling to provide written informed consent.
  • Paroxysmal or persistent atrial fibrillation.
  • Other known cause of PE related symptoms.

研究组 & 干预措施

CTEPH/CTED work-up

Other

干预措施: CTEPH/CTED work-up (Diagnostic Test)

结局指标

主要结局

Prevalence of CTED

时间窗: 3 years

次要结局

  • Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.(3 years)

研究者

申办方类型
Other
责任方
Sponsor

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