- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03231384
Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
24 mars 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
31
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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-
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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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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Experimentell: 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.
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of RIC after acute ischemic stroke
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Objective signs of tissue or neurovascular injury
Tidsram: 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
Tidsram: 7(±24h)days
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7(±24h)days
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Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Tidsram: 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).
Tidsram: 90( ±7days) days
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90( ±7days) days
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functional outcome assessed by Barthel Index(BI)
Tidsram: 90( ±7days)days
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90( ±7days)days
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cerebral infarct volume.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum IL-6
Tidsram: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HS-CRP
Tidsram: baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HCY
Tidsram: baseline and 7(±2)days
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baseline and 7(±2)days
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Any adverse events
Tidsram: 90(±7)days
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90(±7)days
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Samarbetspartners och utredare
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Sponsor
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 (Faktisk)
10 augusti 2017
Primärt slutförande (Faktisk)
30 oktober 2017
Avslutad studie (Faktisk)
14 februari 2018
Studieregistreringsdatum
Först inskickad
5 juli 2017
Först inskickad som uppfyllde QC-kriterierna
24 juli 2017
Första postat (Faktisk)
27 juli 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 mars 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 mars 2018
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RIC/rtPA
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