Acute Ischemic Stroke, Cerebral Embolism and Thrombosis Clinical Trial
— tripcaisOfficial title:
The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.
| Verified date | August 2021 |
| Source | First Affiliated Hospital Xi'an Jiaotong University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | October 31, 2020 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | mortality rate | three-month mortality rate | up to 3 months. | |
| Other | the rate of symptomatic hemorrhagic transformation | Defined by European Cooperative Acute Stroke Study III classification | up to 36 hours | |
| Other | Early neurological deterioration | up to 24 hours after IV tPA | ||
| Other | The tolerance index | the proportion of patients that could complete every RIPC treatment session during his/her hospital stay. | up to 14 days | |
| Primary | the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS). | Day 90 | ||
| Secondary | the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS | we measured how many patients achieved a score of 0 or 1 for the NIHSS, 95 for the BI, and 0 - 2 for the mRS. | Day 90 and at discharge(up to day 14) | |
| Secondary | Plasma biomarker concentrations | Venous blood was drawn before the administration of IV tPA and at the end of hospitalization to determine the effect of repeated RIPC on anti-inflammatory (S100-ß), vascular (VEGF, bFGF), anti-edema (MMP9), anti-oxidants (OH1) and other pathways (BDNF, HSP). | Day 1 and at discharge ( up to day 14) |