One Year Mortality and Morbidity With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Cohort Study

NCT06560983 | Recruiting DMC

• 1 other identifier: 6-11E2
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The "One Year Mortality and Morbidity Outcome with Hyperglycemia among Acute Cerebrovascular Accident Patients in Emergency Department" is an extensive prospective cohort study designed to look into how hyperglycemia affects the short- and long-term outcomes of patients who present to the emergency room with acute cerebrovascular accidents (CVAs). Worldwide, cerebrovascular accidents are a major source of both death and morbidity. Research on the long-term consequences of hyperglycemia and its association with worse outcomes during the acute period of stroke is still underway. This study aims to close this information gap by investigating the relationship between the rates of immediate short- and one-year mortality rates and morbidity and hyperglycemia at the time of CVA presentation. The research design adopts a prospective cohort approach, aligning with established guidelines to ensure methodological rigor. Systematic random sampling will be employed, with a calculated sample size of 60. Patients with acute cerebrovascular accidents who are admitted to the emergency department will be a carefully chosen group for the research. The investigators will carefully gather important data, such as baseline clinical parameters, medical history, demographics, and blood glucose levels upon admission. Throughout a year, follow-up evaluations will be carried out regularly to monitor death rates and evaluate functional and neurological results in research participants using the modified Rankin score. The study will use a structured questionnaire for data collection, involving chart review and face-to-face interviews at specified intervals. Data analysis will include bivariate analysis, logistic regression, and Kaplan-Meier analysis to identify predictors of mortality and morbidity. The ultimate goal of this research is to improve patient care, prognosis, and long-term quality of life for those impacted by this critical medical condition by illuminating the prolonged effects of hyperglycemia in acute cerebrovascular accident patients and deepening our understanding of the intricate interactions between metabolic factors and stroke outcomes.

Conditions

Cardiovascular Diseases

Keywords

Acute Stroke; Hyperglycemia; mortality

Outcome Measures

Primary Outcomes (2)

• Mortality outcomes among hyperglycemic patients with acute stroke in the Emergency Department.

  Outcome Measure: Mortality rate among hyperglycemic patients with acute stroke. Unit of Measure: Percentage (%) or absolute number of deaths.

  1, 3, and 12 months

• Morbidity outcomes among hyperglycemic patients with acute stroke in the Emergency Department.

  Outcome Measure: Morbidity as assessed by the Modified Rankin Scale (MRS). Unit of Measure: MRS score (scale of 1 to 5). Morbidity Assessment: The Modified Rankin Scale (MRS) will be used to quantify the degree of functional impairment or disability resulting from the acute stroke. The MRS score ranges from 1 to 5, with 1 indicating minimal symptoms and 5 representing severe disability or bedridden status.

  1, 3, and 12 months

Secondary Outcomes (5)

• Demographic Characteristics and Mortality Outcomes

  1, 3, and 12 months

• Type of Stroke and Mortality Outcomes

  1, 3, and 12 months

• Clinical History and Mortality Outcomes

  1, 3, and 12 months

• Laboratory Parameters and Mortality Outcomes

  1, 3, and 12 months

• Treatment and Mortality Outcomes

  1, 3, and 12 months

Study Arms (1)

Acute stroke with hyperglycemia

Exposed group signifies acute stroke presenting in emergency department with hyperglycemia

Other: The investigators are planning to do a observational cohort study, hence won't be doing any intervention.

Interventions

The investigators are planning to do a observational cohort study, hence won't be doing any intervention. OTHER

The investigators won't be doing any intervention since this is an observational study.

Acute stroke with hyperglycemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Cohort: Acute Stroke Patients * Sampling Frame: Individuals presenting with acute stroke in the Emergency Room * Sampling Unit: Acute stroke patients with concurrent hyperglycemia

You may qualify if:

• Individuals exhibiting BEFAST-positive symptoms - meeting at least one of the criteria within 24 hours of symptom onset.
• Confirmation of acute stroke through CT imaging.
• Participants aged over 40 years.

You may not qualify if:

• Patients presenting with hypoglycemia
• Transient Ischemic Attack (TIA).
• Subdural hematoma cases.
• Subarachnoid hemorrhage cases.
• Diabetic Ketoacidosis.
• Conditions mimicking stroke symptoms (e.g., sepsis, metabolic derangement, space-occupying lesions, hepatic encephalopathy).
• History of bedridden patients.
• Acute-on-chronic stroke cases.
• Patients requiring assistance in daily activities.
• History of trauma preceding the stroke.

Sponsors & Collaborators

• Institute of medicine, Maharagjung medical campus: lead

Study Sites (2)

Bibek Rajbhandari

Kathmandu, Bagmati, 44600, Nepal

NOT YET RECRUITING

Bibek Rajbhandari

Kathmandu, Bagmati, 44600, Nepal

RECRUITING

Related Publications (10)

• GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

  PMID: 30871944 BACKGROUND

• Bender M, Jusufovic E, Railic V, Kelava S, Tinjak S, Dzevdetbegovic D, Mot D, Tresnjo M, Lakicevic S, Pejanovic-Skobic N, Sinanovic O. High Burden of Stroke Risk Factors in Developing Country: the Case Study of Bosnia-Herzegovina. Mater Sociomed. 2017 Dec;29(4):277-279. doi: 10.5455/msm.2017.29.277-279.

  PMID: 29284999 BACKGROUND

• Lindsay MP, Norrving B, Sacco RL, Brainin M, Hacke W, Martins S, Pandian J, Feigin V. World Stroke Organization (WSO): Global Stroke Fact Sheet 2019. Int J Stroke. 2019 Oct;14(8):806-817. doi: 10.1177/1747493019881353. No abstract available.

  PMID: 31658892 BACKGROUND

• Pandian JD, Sudhan P. Stroke epidemiology and stroke care services in India. J Stroke. 2013 Sep;15(3):128-34. doi: 10.5853/jos.2013.15.3.128. Epub 2013 Sep 27.

  PMID: 24396806 BACKGROUND

• Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.

  PMID: 19233729 BACKGROUND

• Donkor ES. Stroke in the 21st Century: A Snapshot of the Burden, Epidemiology, and Quality of Life. Stroke Res Treat. 2018 Nov 27;2018:3238165. doi: 10.1155/2018/3238165. eCollection 2018.

  PMID: 30598741 BACKGROUND

• Bates BE, Xie D, Kwong PL, Kurichi JE, Ripley DC, Stineman MG. One-year all-cause mortality after stroke: a prediction model. PM R. 2014 Jun;6(6):473-83. doi: 10.1016/j.pmrj.2013.11.006. Epub 2013 Nov 7.

  PMID: 24211696 BACKGROUND

• Mar J, Masjuan J, Oliva-Moreno J, Gonzalez-Rojas N, Becerra V, Casado MA, Torres C, Yebenes M, Quintana M, Alvarez-Sabin J; CONOCES Investigators Group. Outcomes measured by mortality rates, quality of life and degree of autonomy in the first year in stroke units in Spain. Health Qual Life Outcomes. 2015 Mar 17;13:36. doi: 10.1186/s12955-015-0230-8.

  PMID: 25889480 BACKGROUND

• Liljehult J, Christensen T, Christensen KB. Early Prediction of One-Year Mortality in Ischemic and Haemorrhagic Stroke. J Stroke Cerebrovasc Dis. 2020 Apr;29(4):104667. doi: 10.1016/j.jstrokecerebrovasdis.2020.104667. Epub 2020 Feb 8.

  PMID: 32044222 BACKGROUND

• Goulart AC, Bensenor IM, Fernandes TG, Alencar AP, Fedeli LM, Lotufo PA. Early and one-year stroke case fatality in Sao Paulo, Brazil: applying the World Health Organization's stroke STEPS. J Stroke Cerebrovasc Dis. 2012 Nov;21(8):832-8. doi: 10.1016/j.jstrokecerebrovasdis.2011.04.017. Epub 2011 Jun 25.

  PMID: 21705233 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke; Hyperglycemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Bibek Rajbhandari, masters

CONTACT

9851281884; bibekrajbhandarimg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 19, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

NE (2)