- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01672515
Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
22. august 2012 opdateret af: 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Fase 2
- Fase 1
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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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 navne:
|
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.
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
|
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
|
3 days after RIPC treatment.
|
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
|
15 days after RIPC treatment.
|
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 |
Foranstaltningsbeskrivelse |
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.
|
Acute phase of ischemic stroke, and before RIPC treatment
|
Infarct volume after RIPC treatment in ischemic stroke patients
Tidsramme: 30 days after RIPC treatment in ischemic stroke patients
|
Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment
|
30 days after RIPC treatment in ischemic stroke patients
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. oktober 2012
Primær færdiggørelse (Forventet)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
19. august 2012
Først indsendt, der opfyldte QC-kriterier
22. august 2012
Først opslået (Skøn)
27. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-RIPC-cerebral infarction
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med RIPC group
-
Helsinki University Central HospitalAcademy of Finland; Finska Läkaresällskapet (funding); Helsinki University...Rekruttering
-
Oladipupo Olafiranye, MD, MSNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, ikke rekrutterendeKontrast-induceret akut nyreskadeForenede Stater
-
Liverpool John Moores UniversityAfsluttetRisiko for hjertekarsygdommeDet Forenede Kongerige
-
Westfälische Wilhelms-Universität MünsterRekrutteringSepsis | Akut nyreskade | Kritisk sygTyskland
-
Seoul National University HospitalAfsluttetIskæmisk reperfusionsskade | Strålebehandling | Anden rekonstruktiv kirurgiKorea, Republikken
-
Seoul National University HospitalAfsluttetFjern iskæmisk prækonditioneringKorea, Republikken
-
Fundación Centro Nacional de Investigaciones Cardiovasculares...European CommissionRekrutteringLymfom | Antracyklin-induceret hjertetoksicitetHolland, Spanien, Danmark, Tyskland, Frankrig, Portugal
-
Shanghai Zhongshan HospitalAfsluttet
-
Changi General HospitalUniversity College Hospital GalwayAfsluttetKontrastinduceret nefropati | Fjern iskæmisk prækonditioneringSingapore
-
Mid Western Regional Hospital, IrelandUkendtPerifer vaskulær sygdomIrland