Clinical trial NCT03218293: Thrombolysis and RIPC in Acute Ischemic Stroke
Official title: The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke, Cerebral Embolism and Thrombosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).


Eligibility criteria: Inclusion Criteria:

* In accordance with the Guideline of Thrombolysis in Acute Ischemic Stroke and accomplish intravenous thrombolytic therapy using alteplase;
* The consciousness of patients are conscious,somnolence,confusion and stupor，can comply better with the RIPC treatment;
* Acute ischemic stroke confirmed by cranial CT/MRI;
* Provision of written informed consent.

Exclusion criteria:

* History of cerebral embolism,cerebral hemorrhage, brain tumor, brain trauma or other brain lesion;
* Severe cardiac, liver, or kidney disease, malignancy, systemic organ dysfunction;
* Blood pressure \<90/60 mmHg or \>200/110 mmHg after treatment;
* Dementia or mental illness;
* History of major surgery or trauma 4 weeks prior to admission;
* Failure to provide informed consent.

Primary outcomes:
measure: the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS).
timeFrame: Day 90
Secondary outcomes:
measure: the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS
timeFrame: Day 90 and at discharge(up to day 14)
measure: Plasma biomarker concentrations
timeFrame: Day 1 and at discharge ( up to day 14)
Other outcomes:
measure: mortality rate
timeFrame: up to 3 months.
measure: the rate of symptomatic hemorrhagic transformation
timeFrame: up to 36 hours
measure: Early neurological deterioration
timeFrame: up to 24 hours after IV tPA
measure: The tolerance index
timeFrame: up to 14 days
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guogang Luo, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: An JQ, Cheng YW, Guo YC, Wei M, Gong MJ, Tang YL, Yuan XY, Song WF, Mu CY, Zhang AF, Saguner AM, Li GL, Luo GG. Safety and efficacy of remote ischemic postconditioning after thrombolysis in patients with stroke. Neurology. 2020 Dec 15;95(24):e3355-e3363. doi: 10.1212/WNL.0000000000010884. Epub 2020 Oct 7.