Clinical trial NCT01734629: Pulmonary Disease in Patients Referred for Coronary CT
Official title: Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atheroscleroses
COPD
Respiratory Diseases
Keywords: Coronary Disease
COPD
Spirometry
Coronary tomography
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 205
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 40 years old refereed to coronary CT in the investigator´s institution.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Coronary Calcium Score
timeFrame: Baseline
Secondary outcomes:
measure: Coronary obstruction on CT
timeFrame: Baseline
measure: Hospital Admissions
timeFrame: 1 year
measure: ER visits
timeFrame: 1 year
measure: Fatal and non fatal cardiac or respiratory events
timeFrame: 1 year
Other outcomes:
measure: Smoking Status
timeFrame: 1 year
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Incor - HCFMUSP
name: Alberto Cukier, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes FLA, Carvalho-Pinto RM, Stelmach R, Salge JM, Rochitte CE, Souza ECDS, Pessi JD, Cukier A. Spirometry in patients screened for coronary artery disease: is it useful? J Bras Pneumol. 2018 Jul-Aug;44(4):299-306. doi: 10.1590/S1806-37562017000000276.