Clinical trial NCT04170647: Efficacy of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions
Official title: Reperfusion Rates of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions and Predictor Factors of Recanalization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Ischemic
Stroke, Acute
Keywords: reperfusion
IVT
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients presented at our hospital with LVO confirmed who received both intravenous tissue-type plasminogen activator and subsequent repeat angiography will be included in our study.

Brief summary: This is an observational prospective study about the reperfusion rate of intravenous thrombolysis on ischemic stroke patients with large vessel occlusions and predictor factors of successful recanalization.

Detailed description: Stroke is one the most common cause of mortality and disabilities in the world, with the highest incidence in East Asia. Current American Stroke Association (ASA) and European Stroke Organisation (ESO) guidelines recommend bridging therapy with IVT for all eligible patients before indicating endovascular thrombectomy (EVT) for those with large vessel occlusions (LVO). Nevertheless, the decision to use IVT on stroke patients with LVO is still debatable, with many arguments against and supporting combined therapy or direct mechanical thrombectomy. At present, guideline in our hospital advocates the use of IVT in all patients who meet eligibility criteria and present within the 4,5 hour window for anterior circulation stroke and within 24 hour window for posterior circulation stroke. Due to the overcrowded nature of our center as a high-end specialization establishment in Vietnam, it is noted that our door-to-groin time is sub-optimal. This fact inadvertently prolongs the time of action of intravenous tissue-type plasminogen activator before the re-assessment of occlusion site on interventional radiography. Therefore, it is possible for us to better estimate the reperfusion effectiveness of IVT as well as analyse other factors that might have an influence on this rate. The goal of our study is to determine the recanalization rate of IVT and related predictor factors in AIS patients.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older with consent form signed.
2. Patients hospitalized in 115 People's Hospital for acute ischemic stroke.
3. Patients receiving full dose of IVT, with a confirmed LVO (including MCA M1, MCA M2, ICA, BA and VA) on angiography and repeat vascular imaging within 24 hours of hospitalization.

Exclusion Criteria:

1. Patients with evidence of chronic occlusion of large vessels.
2. Patients without source angiography data to assess the characteristics of thrombus

Primary outcomes:
measure: reperfusion rate
timeFrame: within 24 hours of hospitalization
Secondary outcomes:
measure: symptomatic intracerebral hemorrhage
timeFrame: 48 hours after initiation of IVT
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: 115 People's Hospital
Study officials:
References: