Pulmonary Disease in Patients Referred for Coronary CT

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; COPD; Respiratory Diseases; Atheroscleroses

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 40 years old refereed to coronary CT in the investigator´s institution.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coronary CT Spirometry Cohort; Patients refereed to coronary CT enrolled in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Hospital Admissions	Hospital admissions will be accessed after one year from enrollment and compared between groups	1 year
ER visits	ER visits will be accessed after one year from enrollment and compared between groups	1 year
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Status	All endpoints will be evaluated in smoking and nonsmoking subgroups.	1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Alberto Cukier, MD PHD, InCor - HCFMUSP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Spirometry; Coronary Disease; Coronary tomography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Atherosclerosis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2011/02814-0 FAPESP; 0503/11 (Other Identifier: CAPPesq HCFMUSP)