One-Year Outcomes in Acute Strokes with Hyperglycemia in Low Resource Settings (SHAPE): A Prospective Cohort Study Protocol
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Background
Stroke is a significant global health issue, serving as a leading cause of death and disability. The burden of this condition is especially severe in low- and middle-income countries, where the majority of stroke-related fatalities occur. Hyperglycemia, a common metabolic disturbance observed in acute stroke patients, is known to worsen clinical outcomes, contributing to higher rates of mortality and morbidity. This study aims to investigate the relationship between hyperglycemia, morbidity and mortality outcomes in patients with acute stroke, assessing how varying glycemic levels influence short-term (1 month), mid-term (3 months), and long-term (1 year) mortality rates.
Methods
The SHAPE study is a prospective cohort study conducted at the Emergency Department of Tribhuvan University Teaching Hospital (TUTH). The study will enroll adults aged over 40 who present with BEFAST-positive symptoms of acute stroke, confirmed through CT/MRI imaging. Participants will be classified into two groups: those exhibiting hyperglycemia (exposed group) and those with normal glycemic levels (unexposed group). Sixty participants will be recruited (30 hyperglycemic and 30 normoglycemic) and followed for one year to assess mortality and functional outcomes using the modified Rankin Scale (mRS). Data collection will involve regular follow-ups through phone calls, clinic visits, and home visits at 1, 3, and 12 months post-stroke. The analysis will include bivariate comparisons for categorical and continuous variables, logistic regression to identify independent predictors of mortality and functional outcomes, and Kaplan-Meier analysis for assessing survival rates.
Ethical Considerations
The SHAPE Study was approved by the Ethics Review Committee of the Institute of Medicine (Ref no.. 6-11E2), and written informed consent will be obtained from all participants. Results will be disseminated via a peer-reviewed journal.
Trial registration number
ClinicalTrials.gov ID NCT06560983
