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- Klinische proef NCT02267941
Risk Factors for Aortic Dissection in the Chinese Patients
15 oktober 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
3045
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- Aortic dissection
- Acute stage
Exclusion Criteria:
-Simple aortic aneurysm and pseudoaneurysm were excluded.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Risk factor for aortic dissection in Chinese pupolation
Tijdsspanne: Risk factor
|
Risk factor
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2011
Primaire voltooiing (Werkelijk)
1 januari 2011
Studie voltooiing (Werkelijk)
1 december 2013
Studieregistratiedata
Eerst ingediend
20 september 2014
Eerst ingediend dat voldeed aan de QC-criteria
15 oktober 2014
Eerst geplaatst (Schatting)
20 oktober 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
20 oktober 2014
Laatste update ingediend die voldeed aan QC-criteria
15 oktober 2014
Laatst geverifieerd
1 december 2013
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GHBeijing-20140702
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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