- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02297633
Evaluation of Reactive Oxygen Metabolites in the Value of COPD
19. november 2014 opdateret af: Jie liu, Beijing Chao Yang Hospital
System Evaluation of Reactive Oxygen Metabolites in the Value of Chronic Obstructive Pulmonary Disease
This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD.
Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype).
Explore the new oxidative stress evaluation index ROMs application value in COPD.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Reactive oxygen metabolites (reactive oxygen metabolites, ROMs) test is a method by measuring the total reactive oxygen metabolites (ROMs) content in blood so as to evaluate the overall level of oxidative stress in the human body .Our previous studies have established the method of detecting ROMs which is suitable for fully automatic biochemical analyser.Our study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD.
Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype).
Explore the new oxidative stress evaluation index ROMs application value in COPD.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
320
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100020
- Rekruttering
- Respiratory Institute;Beijing chaoyang hospital
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Ledende efterforsker:
- Jie Liu
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Kontakt:
- Jie Liu, Master
- Telefonnummer: 18811225394
- E-mail: chaoyangliujie@163.com
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Ledende efterforsker:
- Xiaoning Bu, Doctor
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Underforsker:
- Hong Zhang, Master
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Underforsker:
- Xiaohong Chang
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Underforsker:
- Baomei Wu
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Underforsker:
- Jingyu Quan
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Ledende efterforsker:
- Huimin Gong
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Ledende efterforsker:
- Hongyan Pang
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Chaoyang hospital clinic
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of COPD according to GOLD 2013
Exclusion Criteria:
- A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Stability in patients with COPD
Those patients diagnosed COPD according to the GOLD guideline and without acute exacerbation within one month.
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AECOPD
the diagnosis of an exacerbation relies exclusively on the clinical presentation of the patient complaining of an acute change of symptoms (baseline dyspnea, cough, and/or sputum production) that is beyond normal day-to-day variation.
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Healthy persons without smoking
The healthy people who do not smoke
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Healthy persons with smoking
Healthy persons who smoke
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The different levels of the ROMs among different groups
Tidsramme: 3 years
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Apply the analysis of variance to compare the different levels of ROMs among the four different groups
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3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The differences of the ROMs among the different lung function levels in the stable stage of COPD group
Tidsramme: 3 years
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Apply the analysis of variance to compare the differences of the ROMs among the lung function levels in the stable stage of COPD group.
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3 years
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The relevance of the ROMs with the lung function levels in the stable stage of COPD group
Tidsramme: 3 years
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Apply Pearson correlation to compare relevance the of the ROMs with the lung function levels in the stable stage of COPD group.
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3 years
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The relevance of the ROMs with the score of mMRC in the stable stage of COPD group
Tidsramme: 3 years
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Apply Pearson correlation to compare relevance the of the ROMs with score of mMRC in the stable stage of COPD group.
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3 years
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The relevance of the ROMs with the score of CAT in the stable stage of COPD group
Tidsramme: 3 years
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Apply Pearson correlation to compare relevance the of the ROMs with score of CAT in the stable stage of COPD group.
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3 years
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The relevance of the ROMs with the numbers of exacerbation in the stable stage of COPD group
Tidsramme: 3 years
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Apply Pearson correlation to compare relevance the of the ROMs with numbers of exacerbation in the stable stage of COPD group.
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Ting Yang, Doctor, Respiratory Institute, Beijing chaoyang hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2014
Primær færdiggørelse (Forventet)
1. maj 2017
Studieafslutning (Forventet)
1. juli 2017
Datoer for studieregistrering
Først indsendt
17. november 2014
Først indsendt, der opfyldte QC-kriterier
19. november 2014
Først opslået (Skøn)
21. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BJCYYT-12345
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