A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)
21. april 2016 opdateret af: Zhiming Zhu, Third Military Medical University
Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality.
Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD.
The therapeutic effects of lower extremity interventional treatment, varied in different reports.
It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on.
More risk factors are still unknown.
The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chongqing, Kina, 400042
- Rekruttering
- The third hospital affiliated to the Third Military Medical University
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Kontakt:
- Zhiming Zhu, MD, PhD
- Telefonnummer: 86-023-68705094
- E-mail: zhuzm@yahoo.com
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Ledende efterforsker:
- Zhiming Zhu, MD, PhD
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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 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, age between 40-90 years old.
- Ankle-brachial index(ABI)<0.9.
- Lower extremity arterial CT shows that the arterial stenosis>50%
Exclusion Criteria:
- Type 2 diabetes with acute complications.
- Type 1 diabetes.
- Cerebrovascular diseases in the last 3 months.
- Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
- Hemorrhagic disease.
- Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy.
- History of dialysis.
- Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- Fertile woman without contraceptives.
- Allergic to iodine.
- Unable to understanding and follow the study protocol orientations.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Interventional Therapy
Percutaneous transluminal angioplasty.
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Ingen indgriben: Non-Interventional Therapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ankle-brachial index
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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Mortality(%)
Tidsramme: 1 year(End of Trial)
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1 year(End of Trial)
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Incidence of amputation(%)
Tidsramme: 1 year(End of Trial)
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1 year(End of Trial)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of major adverse cardiac events (MACE)(%)
Tidsramme: 1 year(End of Trial)
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1 year(End of Trial)
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High-sensitive C reactive protein(mg/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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Fasting plasma glucose(mmol/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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Blood pressure(mmHg)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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HbA1c(%)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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triglyceride(mmol/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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total cholesterol(mmol/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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LDL-c(mmol/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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HDL-c(mmol/L)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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The lower limb transcutaneous oxygen pressure(mmHg)
Tidsramme: Change from baseline at 1 year(End of Trial)
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Change from baseline at 1 year(End of Trial)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. marts 2016
Primær færdiggørelse (Forventet)
1. februar 2020
Studieafslutning (Forventet)
1. maj 2020
Datoer for studieregistrering
Først indsendt
17. marts 2016
Først indsendt, der opfyldte QC-kriterier
21. april 2016
Først opslået (Skøn)
26. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EILRF
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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