ABSTRACT
Background@#and Purpose The benefit regarding co-treatment with intravenous (IV) thrombolysis before mechanical thrombectomy in acute ischemic stroke with large vessel occlusion remains unclear. To test the hypothesis that clinical outcome of ischemic stroke patients with intracranial internal carotid artery, middle cerebral artery or basilar artery occlusion treated with direct endovascular thrombectomy within 4.5 hours will be non-inferior compared with that of standard bridging IV thrombolysis followed by endovascular thrombectomy. @*Methods@#To randomize 780 patients 1:1 to direct thrombectomy or bridging IV thrombolysis with thrombectomy. An international-multicenter prospective randomized open label blinded endpoint trial (PROBE) (ClincalTrials.gov identifier: NCT03494920). @*Results@#Primary endpoint is functional independence defined as modified Rankin Scale (mRS) 0–2 or return to baseline at 90 days. Secondary end points include ordinal mRS analysis, good angiographic reperfusion (modified Thrombolysis in Cerebral Infarction score [mTICI] 2b–3), safety endpoints include symptomatic intracerebral hemorrhage and death. @*Conclusions@#DIRECT-SAFE will provide unique information regarding the impact of direct thrombectomy in patients with large vessel occlusion, including patients with basilar artery occlusion, with comparison across different ethnic groups.
ABSTRACT
Objectives.@#There is no existing Vietnamese diabetes knowledge questionnaire. This impedes assessment of patient knowledge that will be helpful in providing effective diabetes intervention. We aimed to validate the Vietnamese Translated Diabetes Knowledge Questionnaire (DKQ).@*Methodology@#Translation and adaptation strictly followed the guidelines of Beaton et al. Internal consistency was assessed by Cronbach’s alpha coefficient, test-retest reliability was assessed by Fleiss’ Kappa coefficient, and validity value was determined among type 2 diabetes patients in a general hospital.@*Results@#The Vietnamese version of the DKQ had good internal consistency (Cronbach’s alpha for all items = 0.898) and stability (Kappa coefficient >0.600). The average score for all equivalence criteria was 1.00, demonstrating good equivalence to the original. The significant difference between knowledge score and education level (p <0.001) confirmed construct validity.@*Conclusion@#Our study provided a reliable Vietnamese version of the DKQ. Future studies may apply the version in different regions in Vietnam to determine external validity.
Subject(s)
Southeast Asian PeopleABSTRACT
Background@#and Purpose Although onset-to-treatment time is associated with early clinical recovery in acute ischemic stroke (AIS) patients treated with intravenous tissue plasminogen activator (tPA), the effect of the timing of tPA-induced recanalization on functional outcomes remains debatable. @*Methods@#We conducted a multicenter, prospective observational cohort study to determine whether early (within 1-hour from tPA-bolus) complete or partial recanalization assessed during 2-hour real-time transcranial Doppler monitoring is associated with improved outcomes in patients with proximal occlusions. Outcome events included dramatic clinical recovery (DCR) within 2 and 24-hours from tPA-bolus, 3-month mortality, favorable functional outcome (FFO) and functional independence (FI) defined as modified Rankin Scale (mRS) scores of 0–1 and 0–2 respectively. @*Results@#We enrolled 480 AIS patients (mean age 66±15 years, 60% men, baseline National Institutes of Health Stroke Scale score 15). Patients with early recanalization (53%) had significantly (P<0.001) higher rates of DCR at 2-hour (54% vs. 10%) and 24-hour (63% vs. 22%), 3-month FFO (67% vs. 28%) and FI (81% vs. 39%). Three-month mortality rates (6% vs. 17%) and distribution of 3-month mRS scores were significantly lower in the early recanalization group. After adjusting for potential confounders, early recanalization was independently associated with higher odds of 3-month FFO (odds ratio [OR], 6.19; 95% confidence interval [CI], 3.88 to 9.88) and lower likelihood of 3-month mortality (OR, 0.34; 95% CI, 0.17 to 0.67). Onset to treatment time correlated to the elapsed time between tPA-bolus and recanalization (unstandardized linear regression coefficient, 0.13; 95% CI, 0.06 to 0.19). @*Conclusions@#Earlier tPA treatment after stroke onset is associated with faster tPA-induced recanalization. Earlier onset-to-recanalization time results in improved functional recovery and survival in AIS patients with proximal intracranial occlusions.