- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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SP
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Sao Paulo, SP, Brasilien, 05403-000
- Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Coronary Calcium Score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Coronary obstruction on CT
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Smoking Status
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Alberto Cukier, MD PHD, Incor - HCFMUSP
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011/02814-0 FAPESP
- 0503/11 (Annan identifierare: CAPPesq HCFMUSP)
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