Preliminary Registration Detail

Research Registry No : PLRID-00527_V9
 
Postgraduate Research : No
 
University Departmental Research : Yes
 
Name of University : University of Medicine 1, Yangon
 
Department : Department of Neurology
 
Registration Date : 2020-03-05
 
Principle Investigator : WIN MIN THIT
 
Co-Investigators : MOE MOE ZAW, HLA HLA WIN, SAN OO, MYINT OO, OHNMAR, YAMIN KYAW, KHIN MYAT PO PO KYAW
 
Title of Research : Incidence and risk factors of acute ischemic stroke patients: hospital-based study at Yangon and Mandalay General Hospital
 
Field of Research : Neurology
 
Preliminary Research Design : Analytic Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : Stroke is the third leading cause of death worldwide and a major cause of disability (Hankey et al,2000). Stroke is a common medical emergency with an annual incidence of between 180 and 300 per 100,000. Among patients presenting with stroke, ischaemic events constitute over 85% and the remainder will have an intracerebral haemorrhage (Allen and Lueck, 2010). In 2016, total incidence of ischaemic stroke in patients admitted to Yangon General Hospital was 4968 (Annual Hospital statistics, 2016). In 2017, admissions of ischaemic patients at YGH were 4597 (Annual Hospital statistics, 2017). In Yangon Gereral Hospital, stroke mortality was (7%) in 2016 and (6%) in 2017 (Annual Hospital statistics 2016 ,2017). Ischaemic stroke subtype distribution varies in populations of different races and ethnicities because of asymmetric prevalence of vascular risk factors as a result of different life styles and intrinsic genetic clustering. Studies have shown that stroke subtypes and risk factors of Asian populations are different from Europeans. In Western countries, cardioembolism is regarded as the most common cause of stroke since the prevalence of ischaemic strokes attributed to large artery disease in these countries is steadily declining, probably due to intensive medical management of atherosclerotic risk factors (Radu et al, 2017).On the contrary, large artery atherosclerosis is the most commonly found vascular lesion in Asian acute stroke patients being responsible for one third of strokes in Chinese population (Arenillas et al,2001). Symptomatic large artery atherosclerosis is associated with a greater risk of recurrent stroke than cardioembolism. Ischemic stroke subtype according to the TOAST criteria is a significant predictor for long-term survival (Renjen et al,2015). There are 5 major categories of ischaemic stroke according to TOAST classification (Trial of ORG 10172 in Acute Stroke Treatment ) . These are - 1.large-artery atherosclerosis, including large artery thrombosis and artery-to-artery embolism, 2. cardio-embolism, 3. small artery occlusion(lacune), 4. stroke of other determined cause and 5.stroke of un-determined cause (Two or more causes identified, negative evaluation,or incomplete evaluation ) (Renjen et al,2015). Several well-established modifiable risk factors for stroke are hypertension, diabetes mellitus, smoking, cardiac disease and hyperlipidaemia. There has been increasing number of studies on distribution on risk factors of ischaemic stroke in various countries and various populations since studies have found out that risk factors can be varied according to race and population. Treatment options of acute ischaemic stroke are thrombolysis and mechanical thrombectomy. Currently in Myanmar, only thrombolytic facilities are available and mechanical thrombectomy cannot be done yet. Even in largest tertiary hospital like Yangon General hospital, only 0.7% of total admitted acute ischaemic stroke patients are able to receive thrombolytic therapy because of restrictions in application time, indication, availability of facilities and expertise (Annual hospital statistics 2016, 2017, 2018). Consequently, most patients are relying on secondary preventive measures mainly antiplatelets and risk modification. In order to do intervention for prevention, the types of ischaemic stroke and risk factors for our population should be identified. Several well-established modifiable risk factors for stroke are hypertension, diabetes mellitus, smoking, cardiac disease and hyperlipidaemia. So, this study aims at comprehensively evaluating various ischaemic stroke subtypes and distribution of contributing risk factors of acute ischaemic stroke patients at biggest tertiary general hospital in Myanmar in order to be helpful in implementing primary and secondary preventive measures of ischemic strokes in Myanmar.
 
Preliminary Aim : To determine the stroke subtypes and risk factors of acute ischemic stroke patients at Yangon General Hospital (YGH) and Mandalay General Hospital (MGH)
 
Preliminary Objectives : 1. To determine the proportion of ischemic stroke patients among total stroke admission 2. To describe the demographic characteristics of patients with ischemic stroke 3. To study the distribution of various ischemic stroke subtypes 4. To find out the various risk factors distribution in ischemic stroke patients
 
Preliminary Sample Size : All acute ischemic stroke patients admitted to Department of Neurology and general medical wards of Yangon General Hospital and and Mandalay General Hospital. All acute ischemic stroke patients will be consecutively recruited according to the inclusion criteria after getting informed consent. Inclusion criteria All consecutive patients with acute ischemic stroke admitted to the above study areas will be included. Exclusion criteria - Haemorrhagic stroke patients - Ischaemic Stroke patients with known autoimmune diseases and CNS infection - Patients less than 13 years of age
 
Preliminary Study Duration : August 2018 –July 2019
 
Preliminary Study Area : Yangon General Hospital and and Mandalay General Hospital
 
Preliminary Study Method : : Hospital based – cross-sectional analytic study
 
Preliminary Research Outcome : demographic variables, ischaemic stroke risk factors
 
Preliminary Research Finding : Prevalence rate of stroke and ischaemic stroke risk factors such as hypertension, hyperlipidaemia and diabetes mellitus.
 
Preliminary Progress Report : This study was started in August (2018). During the study period, total incidence of ischaemic stroke in patients admitted to Yangon General Hospital was (1300). The ischaemic stroke patients admitted to Mandalay General Hospital in this period was (600).
 
Study Starting Date : 2018-08-01
IRB/PRC/ERC Approval Date : 2020-02-25
 
Placement of IRB/PRC/ERC : University of Medicine 1, Yangon
 
IRB/PRC/ERC Approval Letter/Document : 050320200321512018Strokesubtype.pdf
 
Pre-existing Registration ID : 098 / UM1,REC.2018
 
Pre-existing Name of Organization : Department of Neurology
 
Pre-existing Name of Organization Website : -