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Pulmonary Disease in Patients Referred for Coronary CT

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ClinicalTrials.gov Identifier: NCT01734629
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):

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
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 : April 2011
Primary Completion Date : December 2013
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Coronary Calcium Score [ Time Frame: 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 :
  1. Coronary obstruction on CT [ Time Frame: Baseline ]
    Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.

  2. Hospital Admissions [ Time Frame: 1 year ]
    Hospital admissions will be accessed after one year from enrollment and compared between groups

  3. ER visits [ Time Frame: 1 year ]
    ER visits will be accessed after one year from enrollment and compared between groups

  4. Fatal and non fatal cardiac or respiratory events [ Time Frame: 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:
  1. Smoking Status [ Time Frame: 1 year ]
    All endpoints will be evaluated in smoking and nonsmoking subgroups.

Biospecimen Retention:   Samples Without DNA
Blood Samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 40 years old refereed to coronary CT in the investigator´s institution.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734629

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Principal Investigator: Alberto Cukier, MD PHD Incor - HCFMUSP
More Information

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01734629     History of Changes
Other Study ID Numbers: 2011/02814-0 FAPESP
0503/11 ( Other Identifier: CAPPesq HCFMUSP )
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: November 2013

Keywords provided by University of Sao Paulo General Hospital:
Coronary Disease
Coronary tomography

Additional relevant MeSH terms:
Lung Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Respiration Disorders
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases