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临床试验/NCT01734629
NCT01734629已完成不适用

Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
Coronary Calcium Score

研究概览

简要总结

Several studies show an association between chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with physical inactivity, advanced age and systemic inflammation The use of coronary computed tomography (CCT) with multiple detectors is a diagnostic method for coronary disease, describing the anatomy and severity of arterial obstruction. One way of estimating the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.

The aim of this observational study is to establish the correlation between the CCS and lung function. It will also correlate the presence of irreversible airway obstruction with significant coronary lesions.

Patients over 40 years referred to CCT who agree to participate in the study will perform a spirometry with bronchodilator and collect a blood sample to measure serum markers of inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP), tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the general population and in subgroups: smokers, former smokers and nonsmokers.

One year after the CCT patients will be contacted by the investigators and accessed for emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory events.

The investigators hypothesis is that reduced lung function is independently associated with elevated CCS and is, also a risk factor for increased hospital admission and coronary events.

The concomitant assessment of lung function and CCS can contribute knowledge about the epidemiological association between pulmonary disease and CAD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for coronary CT.
  • Age greater than 40 years

排除标准

  • History of myocardial revascularization (surgical or percutaneous)
  • Cognitive-functional incapacity to perform spirometry
  • Contraindication for administration of 400 mcg of albuterol
  • Acute myocardial infarction or unstable angina within 2 weeks
  • Angina pectoris class III or IV according to the Canadian Cardiovascular Society
  • Heart failure New York Heart Association class III or IV

结局指标

主要结局

Coronary Calcium Score

时间窗: Baseline

Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities.

次要结局

  • Coronary obstruction on CT(Baseline)
  • Hospital Admissions(1 year)
  • ER visits(1 year)
  • Fatal and non fatal cardiac or respiratory events(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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