Pulmonary Disease in Patients Referred for Coronary CT

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01734629

Collaborator

(none)

205

Enrollment

Location

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Atheroscleroses COPD Respiratory Diseases

Study Design

Study Type:

Observational

Actual Enrollment :

205 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Coronary CT Spirometry Cohort Patients refereed to coronary CT enrolled in the study.

Outcome Measures

Primary Outcome Measures

Coronary Calcium Score [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 Outcome Measures

Coronary obstruction on CT [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 [1 year]
Hospital admissions will be accessed after one year from enrollment and compared between groups
ER visits [1 year]
ER visits will be accessed after one year from enrollment and compared between groups
Fatal and non fatal cardiac or respiratory events [1 year]
Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups

Other Outcome Measures

Smoking Status [1 year]
All endpoints will be evaluated in smoking and nonsmoking subgroups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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