- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02267941
Risk Factors for Aortic Dissection in the Chinese Patients
15 oktober 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
3045
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Aortic dissection
- Acute stage
Exclusion Criteria:
-Simple aortic aneurysm and pseudoaneurysm were excluded.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Risk factor for aortic dissection in Chinese pupolation
Tidsram: Risk factor
|
Risk factor
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 januari 2011
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
20 september 2014
Först inskickad som uppfyllde QC-kriterierna
15 oktober 2014
Första postat (Uppskatta)
20 oktober 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2014
Senast verifierad
1 december 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GHBeijing-20140702
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