Pulmonary Disease in Patients Referred for Coronary CT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Atheroscleroses COPD Respiratory Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary CT Spirometry Cohort

Patients refereed to coronary CT enrolled in the study.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Cukier, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Incor - HCFMUSP

Locations

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Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED

PMID: 30328928 (View on PubMed)

Other Identifiers

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0503/11

Identifier Type: OTHER

Identifier Source: secondary_id

2011/02814-0 FAPESP

Identifier Type: -

Identifier Source: org_study_id