Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
22. august 2012 oppdatert av: Ji Xunming, Capital Medical University
Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
Stroke is one of the three leading causes of human death, and a major cause of adult disability.
Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction.
Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction.
Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.
Studieoversikt
Detaljert beskrivelse
This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method.
Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days.
Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
It is 200mmHg for RIPC group and 60mmHg for control group.
Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.
Studietype
Intervensjonell
Registrering (Forventet)
80
Fase
- Fase 2
- Fase 1
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
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age between 40 to 80 Years
- Ischemic cerebrovascular disease within 6 hours
- National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
- Cranial CT to rule out the the cerebral hemorrhage
- Written informed consent was
Exclusion Criteria:
- Cerebral hemorrhage
- Other parts of the active bleeding disease
- Atrial fibrillation
- Moyamoya disease or vasculitis
- Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
- Out coagulation disorder
- Severe lesions of severe liver and kidney disease, malignancy or other systemic
- Cannot tolerate BLIPC or without informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: RIPC group
RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
|
Andre navn:
|
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Sham-komparator: Control group
RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Local tissue damage 30 days after RIPC treatment
Tidsramme: 30 days after RIPC treatment
|
Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
|
30 days after RIPC treatment
|
|
Levels of plasma biomarkers assay right before RIPC treatment
Tidsramme: right before RIPC treatment (within 24hrs)
|
levels of CRP、TINF-α、slCAM-1 and GFAP
|
right before RIPC treatment (within 24hrs)
|
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Levels of plasma biomarkers assay 3 days after RIPC treatment.
Tidsramme: 3 days after RIPC treatment.
|
levels of CRP、TINF-α、slCAM-1 and GFAP
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3 days after RIPC treatment.
|
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Levels of plasma biomarkers assay 15 days after RIPC treatment.
Tidsramme: 15 days after RIPC treatment.
|
levels of CRP、TINF-α、slCAM-1 and GFAP
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15 days after RIPC treatment.
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Levels of plasma biomarkers assay 30 days after RIPC treatment
Tidsramme: 30 days after RIPC treatment
|
levels of CRP、TINF-α、slCAM-1 and GFAP
|
30 days after RIPC treatment
|
|
Levels of plasma biomarkers assay right after RIPC treatment
Tidsramme: right after RIPC treatment (within 24hrs)
|
levels of CRP、TINF-α、slCAM-1 and GFAP
|
right after RIPC treatment (within 24hrs)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Infarct volume evaluation before RIPC treatment.
Tidsramme: Acute phase of ischemic stroke, and before RIPC treatment
|
MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
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Acute phase of ischemic stroke, and before RIPC treatment
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Infarct volume after RIPC treatment in ischemic stroke patients
Tidsramme: 30 days after RIPC treatment in ischemic stroke patients
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Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment
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30 days after RIPC treatment in ischemic stroke patients
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. oktober 2012
Primær fullføring (Forventet)
1. oktober 2013
Datoer for studieregistrering
Først innsendt
19. august 2012
Først innsendt som oppfylte QC-kriteriene
22. august 2012
Først lagt ut (Anslag)
27. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2012
Sist bekreftet
1. august 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012-RIPC-cerebral infarction
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