- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734629
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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SP
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Sao Paulo, SP, Brazil, 05403-000
- Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
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Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary Calcium Score
Time Frame: Baseline
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Coronary calcium score is a measurement obtained in coronary computer tomography.
The results will be compared between group with and without spirometric abnormalities.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary obstruction on CT
Time Frame: Baseline
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Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.
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Baseline
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Hospital Admissions
Time Frame: 1 year
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Hospital admissions will be accessed after one year from enrollment and compared between groups
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1 year
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ER visits
Time Frame: 1 year
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ER visits will be accessed after one year from enrollment and compared between groups
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1 year
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Fatal and non fatal cardiac or respiratory events
Time Frame: 1 year
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Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Status
Time Frame: 1 year
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All endpoints will be evaluated in smoking and nonsmoking subgroups.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Alberto Cukier, MD PHD, Incor - HCFMUSP
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/02814-0 FAPESP
- 0503/11 (Other Identifier: CAPPesq HCFMUSP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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