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OpenTrials
Completed

NCT Number: NCT01734629

Pulmonary Disease in Patients Referred for Coronary CT

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Coronary Calcium Score

    Time frame: Baseline

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

Secondary outcomes

  1. Coronary obstruction on CT

    Time frame: Baseline

    Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.

  2. Hospital Admissions

    Time frame: 1 year

    Hospital admissions will be accessed after one year from enrollment and compared between groups

  3. ER visits

    Time frame: 1 year

    ER visits will be accessed after one year from enrollment and compared between groups

  4. Fatal and non fatal cardiac or respiratory events

    Time frame: 1 year

    Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups

Other outcomes

  1. Smoking Status

    Time frame: 1 year

    All endpoints will be evaluated in smoking and nonsmoking subgroups.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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