Pulmonary Disease in Patients Referred for Coronary CT
|ClinicalTrials.gov Identifier: NCT01734629|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : December 3, 2014
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.
|Condition or disease|
|Coronary Artery Disease Atheroscleroses COPD Respiratory Diseases|
|Study Type :||Observational|
|Actual Enrollment :||205 participants|
|Official Title:||Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.|
|Study Start Date :||April 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2014|
Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
- 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.
- 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.
- Hospital Admissions [ Time Frame: 1 year ]Hospital admissions will be accessed after one year from enrollment and compared between groups
- ER visits [ Time Frame: 1 year ]ER visits will be accessed after one year from enrollment and compared between groups
- 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
- Smoking Status [ Time Frame: 1 year ]All endpoints will be evaluated in smoking and nonsmoking subgroups.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734629
|Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|Sao Paulo, SP, Brazil, 05403-000|
|Principal Investigator:||Alberto Cukier, MD PHD||Incor - HCFMUSP|