Pulmonary Disease in Patients Referred for Coronary CT

NCT01734629 | Completed DMC

• 2 other identifiers: 2011/02814-0 FAPESP0503/11
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atheroscleroses; COPD; Respiratory Diseases

Keywords

Coronary Disease; COPD; Spirometry; Coronary tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Coronary obstruction on CT

  Baseline

• Hospital Admissions

  1 year

• ER visits

  1 year

• Fatal and non fatal cardiac or respiratory events

  1 year

Other Outcomes (1)

• Smoking Status

  1 year

Study Arms (1)

Coronary CT Spirometry Cohort

Patients refereed to coronary CT enrolled in the study.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients referred for coronary CT.
• Age greater than 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30328928 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Cukier, MD PHD

  Incor - HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2013-11

Locations

BR (1)