- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02267941
Risk Factors for Aortic Dissection in the Chinese Patients
15. oktober 2014 oppdatert av: Yang Li, General Hospital of Beijing PLA Military Region
Food and Drug Administration in China
To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese patients.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Aortic dissection (AD) is a life-threatening cardiovascular disease with high mortality.
Without optimal treatment, approximately 50% of patients die within one week of the onset of symptoms, and 80% die within 2 weeks.
With the change of life-style and the development of diagnostic technology, the incidence and detection rate of AD were increasing in China recently.
However, the cause remains unclear.
Studies showed that AD were associated with some risk factors, such as hypertension, connective tissue disease, iatrogenic injury, drug, pregnancy, etc.
It is reported that two thirds patients with AD had a history of hypertension; 50% patients aged <40 years were accompanied with hereditary Marfan syndrome; 13~19% had a familial history of aortic aneurysm or dissection.
These epidemiological data were obtained from Caucasian population, however, such information was not available for the Chinese population.
Moreover, epidemiological investigation was absent in China, and the assessment of risk factors for AD was mainly referred to the studies from developed countries.
Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese patients using 3045 individuals from the 15 major centers in China.
We anticipated that this analysis would provide helpful information preventing and controlling AD in China.
Studietype
Observasjonsmessig
Registrering (Faktiske)
3045
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Between January, 2011 and December, 2012, we collected 3045 patients with AAD (1668 with type A and 1377 with type B) from 15 major centers in China as the case group.
As the control group, 2760 patients without AD were obtained from the hospitalized patients in the same period.
Beskrivelse
Inclusion Criteria:
- Aortic dissection
- Acute stage
Exclusion Criteria:
-Simple aortic aneurysm and pseudoaneurysm were excluded.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
case
Diagnosis of aortic dissection was based on history and physical examination, and confirmed by imaging, visualization at surgery, and/or postmortem examination.
According to the Stanford classification system, type A aortic dissection was defined as any dissection that involves the ascending aorta and type B as any that does not.
Acute stage was confined to initial 14 days after symptom onset.
Simple aortic aneurysm and pseudoaneurysm were excluded.
Surgical and endovascular treatments were the main interventions and performed in the case group.
|
Data were collected by a disigned form.
Statistic software was used to analyze clinical data.
|
control
As the control group, 2760 patients without AD were obtained from the hospitalized patients in the same period.
Types of disease in the control group included congenital heart disease (632), coronary heart disease (467), adult valve disease (375), pulmonary artery hypertension (292), appendicitis (234), pneumonia (197), fracture (189), intestinal polyps (167), gallstone (156), esophagus cancer (51).
Patients in the control group were derived from Department of Cardiovascular Surgery, Department of General Surgery, Department of Thoracic Surgery, and Department of Respiration, respectively.
|
Data were collected by a disigned form.
Statistic software was used to analyze clinical data.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Risk factor for aortic dissection in Chinese pupolation
Tidsramme: Risk factor
|
Risk factor
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. januar 2011
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
20. september 2014
Først innsendt som oppfylte QC-kriteriene
15. oktober 2014
Først lagt ut (Anslag)
20. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. oktober 2014
Sist bekreftet
1. desember 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GHBeijing-20140702
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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