- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02162095
Is COPD a Risk Factor for Cardiovascular Disease?
Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Patients with chronic obstructive pulmonary disease (COPD) suffer from significant cardiovascular morbidity and mortality. Coronary artery disease has often been linked causally to COPD, but the exact pathophysiological mechanisms underpinning this association remain speculative. A retrospective case-control study matching COPD patients and controls one to one for smoking history and conventional cardiovascular risk factors will be performed to study the association between COPD and cardiovascular outcomes. Filling in this knowledge gap may contribute to the understanding of the interplay between COPD and cardiovascular disease.
The objective of this retrospective case-control study is to determine whether COPD might be a risk factor for coronary atherosclerosis, impaired left ventricular ejection fraction, and major adverse cardiovascular events independent of conventional cardiovascular risk factors.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Zurich, Schweiz, 8091
- University Hospital Zurich, Pulmonary Division
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- SPECT-CT imaging due to preoperative assessment between 01.01.2007 and 31.07.2013.
- Coronary artery calcium score and left ventricular ejection fraction data available.
- History of smoking (smoker or ex-smoker).
- COPD group: Documented chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC < 0.7).
- Control group: Exclusion of chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC > 0.7).
Exclusion Criteria:
- Known coronary artery disease or coronary symptoms (angina pectoris) at the time of the SPECT-CT investigation.
- Known congenital or structural heart disease.
- Previous heart transplantation.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Chronic obstructive pulmonary disease
Approximately 100 participants with documented chronic obstructive pulmonary disease (post-bronchodilator Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) < 0.7).
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Control
Approximately 100 participants with exclusion of chronic obstructive pulmonary disease (post-bronchodilator Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) > 0.7).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Coronary calcium score in cardiac computed tomography
Tidsram: Up to one month
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Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.
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Up to one month
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Left ventricular ejection fraction in single-photon emission computed tomography
Tidsram: Up to one month
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Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.
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Up to one month
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Major adverse cardiovascular events
Tidsram: Up to three months
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Follow-up via telephone interview for major adverse cardiovascular events.
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Up to three months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Malcolm Kohler, MD, Prof, University of Zurich
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
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SNCTP000000995
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