Pulmonary Disease in Patients Referred for Coronary CT
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Purpose
Several studies show an association between chronic obstructive pulmonary disease (COPD) and ischemic heart disease (IHD). 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 IHD, 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 ECC 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 COPD and IHD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.
| Condition |
|---|
|
Coronary Artery Disease Atheroscleroses COPD Respiratory Diseases |
| Study Type: | Observational |
| Study Design: | 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. |
- Coronary Calcium Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities.
- Coronary obstruction on CT [ Time Frame: Baseline ] [ Designated as safety issue: No ]Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.
- Hospital Admissions [ Time Frame: 1 year ] [ Designated as safety issue: No ]Hospital admissions will be accessed after one year from enrollment and compared between groups
- ER visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]ER visits will be accessed after one year from enrollment and compared between groups
- Fatal and non fatal cardiac or respiratory events [ Time Frame: 1 year ] [ Designated as safety issue: No ]Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups
- Smoking Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]All endpoints will be evaluated in smoking and nonsmoking subgroups.
Biospecimen Retention: Samples Without DNA
Blood Samples
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
500 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| Contact: Frederico LA Fernandes, MD | 55 11 26615034 | frederico.fernandes@incor.usp.br |
| Brazil | |
| Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Contact: Frederico LA Fernandes, MD 55 11 26615034 frederico.fernandes@incor.usp.br | |
| Sub-Investigator: Frederico LA Fernandes, MD | |
| Principal Investigator: | Alberto Cukier, MD PHD | Incor - HCFMUSP |
More Information
No publications provided
| 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 |
| Study First Received: | November 21, 2012 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
Coronary Disease COPD Spirometry Coronary tomography |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Lung Diseases Pulmonary Disease, Chronic Obstructive Respiration Disorders |
Respiratory Tract Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on June 18, 2013