Pulmonary Disease in Patients Referred for Coronary CT

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734629
• Other study ID #: 2011/02814-0 FAPESP
• Secondary ID: 0503/11
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: December 2, 2014
• Start date: April 2011
• Est. completion date: December 2014

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atheroscleroses
• Atherosclerosis
• COPD
• Coronary Artery Disease
• Coronary Disease
• Lung Diseases
• Myocardial Ischemia
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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