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临床试验/NCT03370679
NCT03370679已完成不适用

The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease

Danderyd Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography.

详细描述

The PULSE project consists of four different studies:

  • in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population
  • in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome
  • in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

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

  • Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden

排除标准

  • History of Myocardial Infarction
  • Undergone coronary arterty bypass grafting (CABG)
  • Finding of Heart Failure at echocardiography
  • Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination

结局指标

主要结局

Mortality

时间窗: Average follow-up time 3,5 years

Mortality compared with sex and age-matched control population. Data for Control population obtained via Socialstyrelsen (The Swedish Health Board)

次要结局

  • Cardiovascular morbidity(Average follow-up time 3,5 years)

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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