- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03231384
Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
24. marts 2018 opdateret af: Ji Xunming, Capital Medical University
Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
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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XI Cheng District
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Beijing, XI Cheng District, Kina, 100053
- Xuanwu Hospital, Capital Medical University
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, age≥18;
- Acute ischemic stroke;
- modified Rankin Scale (mRS) score of 2-5;
- mRS score less than 1 before onset of stroke symptom;
- Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
- Good compliance for Remote Ischemic Conditioning(RIC) therapy;
- Informed consent obtained.
Exclusion Criteria:
- Stroke or serious head trauma within the previous 3 months
- Major surgery or severe trauma with in the preceding 3 months
- Intracranial hemorrhage
- Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- Symptoms rapidly improving
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
- Arterial puncture at a noncompressible site within the previous 7 days
- Seizure at the onset of stroke
- Platelet count of less than 100,000 per cubic millimeter
- Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
- Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
- Use or plan to use intervention for diagnosis or treating
- Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation
- severe hepatic or renal dysfunction
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Life expectancy<1 years
- Pregnant or breast-feeding women
- Unwilling to be followed up or poor compliance for treatment
- Patients being enrolled or having been enrolled
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
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Eksperimentel: RIC group
The upper limb ischemic conditioning is composed of five cycles of upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
This therapy started within 2 hours after r-tPA thrombolytic therapy.
In addition, all participants receive a standard clinical therapy.
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In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Doctormate, IPC-906 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of RIC after acute ischemic stroke
Tidsramme: 7 days
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The proportion of enrolled subjects that completed all the designed RIC procedures.
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7 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective signs of tissue or neurovascular injury
Tidsramme: within 7(±24h) days
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objective signs of tissue or neurovascular injury felt to be due to cuff inflation.
Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
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within 7(±24h) days
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Number of participants with intracranial hemorrhage in two groups
Tidsramme: 7(±24h)days
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7(±24h)days
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Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Tidsramme: 7(±24h)days
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7(±24h)days
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The functional outcome at 90 days assessed by modified Rankin scale (mRS).
Tidsramme: 90( ±7days) days
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90( ±7days) days
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functional outcome assessed by Barthel Index(BI)
Tidsramme: 90( ±7days)days
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90( ±7days)days
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cerebral infarct volume.
Tidsramme: 3-7 days after stroke onset
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The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
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3-7 days after stroke onset
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cerebral infarct volume.
Tidsramme: 3-7 days after stroke onset
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The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
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3-7 days after stroke onset
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Cardiovascular parameters during 7 days of RIC treatment.
Tidsramme: 7 days
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the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
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7 days
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the heart rate during 7 days of RIC treatment.
Tidsramme: 7 days
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the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
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7 days
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Levels of plasma myoglobin
Tidsramme: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum IL-6
Tidsramme: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HS-CRP
Tidsramme: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HCY
Tidsramme: baseline and 7(±2)days
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baseline and 7(±2)days
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Any adverse events
Tidsramme: 90(±7)days
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90(±7)days
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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 (Faktiske)
10. august 2017
Primær færdiggørelse (Faktiske)
30. oktober 2017
Studieafslutning (Faktiske)
14. februar 2018
Datoer for studieregistrering
Først indsendt
5. juli 2017
Først indsendt, der opfyldte QC-kriterier
24. juli 2017
Først opslået (Faktiske)
27. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RIC/rtPA
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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