- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Coronary Calcium Score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Coronary obstruction on CT
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Smoking Status
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Alberto Cukier, MD PHD, InCor - HCFMUSP
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2011/02814-0 FAPESP
- 0503/11 (Andere Kennung: CAPPesq HCFMUSP)
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