One-Year Outcomes in Acute Strokes with Hyperglycemia in Low Resource Settings (SHAPE): A Prospective Cohort Study Protocol

Abstract

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

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://clinicaltrials.gov/study/NCT06560983?cond=NCT06560983&rank=1

Funding Statement

No funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

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.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Not applicable

Comments (0)

No login
gif