Coronary Artery Disease Clinical Trial
Official title:
Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.
Verified date | November 2013 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 205 |
Est. completion date | December 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Smoking Status | All endpoints will be evaluated in smoking and nonsmoking subgroups. | 1 year | No |
Primary | Coronary Calcium Score | Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities. | Baseline | No |
Secondary | Coronary obstruction on CT | Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality. | Baseline | No |
Secondary | Hospital Admissions | Hospital admissions will be accessed after one year from enrollment and compared between groups | 1 year | No |
Secondary | ER visits | ER visits will be accessed after one year from enrollment and compared between groups | 1 year | No |
Secondary | Fatal and non fatal cardiac or respiratory events | Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups | 1 year | No |
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