Cardiovascular DiseasesNCT06560983
One Year Mortality and Morbidity With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Cohort Study
An observational study of Cardiovascular Diseases, run by Institute of medicine, Maharagjung medical campus at 2 sites in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- The investigators are planning to do a observational cohort study, hence won't be doing any intervention.
- How many people
- 46 participants
- Where
- 2 sitesNepal
- Study dates
- 15 Jan 2024to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- History of bedridden patients.
- Acute-on-chronic stroke cases.
- Patients requiring assistance in daily activities.
- History of trauma preceding the stroke.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal2 sites, 2 recruiting
- Not yet recruiting
Bibek Rajbhandari
Kathmandu, Bagmati, 44600
Bibek Rajbhandari, MD, 9851281884, bibekrajbhandarimg@gmail.com
- Recruiting
Bibek Rajbhandari
Kathmandu, Bagmati, 44600
Bibek Rajbhandari, MD, 9851281884, bibekrajbhandarimg@gmail.com
About this study
Official title: One Year Mortality and Morbidity Outcome With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Prospective Cohort Study
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.
Read the detailed description
The research design and methodology of this study are meticulously crafted to explore the complex interplay between acute stroke, hyperglycemia, and their impact on mortality and morbidity. This study adopts a prospective cohort design, following a systematic approach inspired by the Critical Appraisal Skills Programme (CASP) cohort study guidelines and adhering strictly to the STROBE (Strengthening the reporting of observational studies in epidemiology), reporting standards. By implementing a quantitative research method, the study aims to provide high-quality evidence through structured and transparent methodology.
The study focuses on individuals presenting with acute stroke in the Emergency Department (ED) of Tribhuvan University Teaching Hospital (TUTH). The high patient volume and the availability of advanced diagnostic tools like CT scans make TUTH's ED an ideal setting for this research. According to internal audits, TUTH's ED receives a significant number of acute stroke patients, ensuring a robust sample for the study. The study will specifically examine acute stroke patients with concurrent hyperglycemia, utilizing a systematic random sampling technique to ensure representative and unbiased selection. The sample size was calculated using proportions from previous international studies, with adjustments for potential loss to follow-up. The final sample size is set at 60 participants, evenly divided between those with hyperglycemia and those with normal glycemic levels, allowing for meaningful comparisons.
The study's dependent variables are mortality and morbidity, assessed at short-term (1 month), mid-term (3 months), and long-term (1 year) intervals. Independent variables include demographic characteristics, clinical history, and laboratory parameters. Matching based on age, sex, stroke type, and other relevant variables is essential to minimize confounding, enhancing the validity and reliability of the study's findings. Data collection will involve chart reviews for baseline characteristics and clinical history, followed by face-to-face interviews at 1 month, 3 months, and 1 year for follow-up assessments. Laboratory analyses will be conducted for blood glucose levels, and CT scans will be utilized to confirm stroke diagnoses and assess severity. Mortality will be tracked within specified time frames, while morbidity will be assessed using the Modified Rankin Score (MRS). Clinical variables such as vital signs, GCS score, and BEFAST criteria will be recorded meticulously. Hemorrhagic and ischemic strokes will be evaluated using specific criteria, including the The intracerebral hemorrhage (ICH) score and The NIH Stroke Scale/Score (NIHSS), respectively. Participants will be recruited through a systematic process at the triage registration desk, with initial assessments based on BEFAST criteria and additional clinical signs. Blood glucose levels will be measured, followed by CT imaging to confirm stroke diagnoses. This structured flow ensures the accurate identification of eligible participants and the collection of relevant data for analysis.
- Conditions
- Cardiovascular Diseases
- Being tested
- The investigators are planning to do a observational cohort study, hence won't be doing any intervention.
- Keywords
- Acute Stroke, Hyperglycemia, mortality
- Medical subject headings
- Cardiovascular Diseases, Stroke, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke with hyperglycemia | Exposed group signifies acute stroke presenting in emergency department with hyperglycemia Receives: Other: The investigators are planning to do a observational cohort study, hence won't be doing any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1, 3, and 12 months
Secondary outcomes (5)
Demographic Characteristics and Mortality Outcomes
Outcome Measure: Mortality rate stratified by demographic characteristics (age, sex, ethnicity, socioeconomic status).
Unit of Measure: Percentage (%) or number of deaths per group.
Measured: 1, 3, and 12 months
Type of Stroke and Mortality Outcomes
Outcome Measure: Mortality rate stratified by type of stroke (ischemic, hemorrhagic, other). Unit of Measure: Percentage (%) or number of deaths per stroke type.
Measured: 1, 3, and 12 months
Clinical History and Mortality Outcomes
Outcome Measure:Mortality rate stratified by clinical history (presence of comorbid conditions, previous strokes, BMI, smoking habits, alcohol consumption). Unit of Measure: Percentage (%) or number of deaths per clinical history category
Measured: 1, 3, and 12 months
Laboratory Parameters and Mortality Outcomes
Outcome Measure: Mortality rate stratified by laboratory parameters (e.g., blood glucose levels, cholesterol levels). Unit of Measure: Percentage (%) or number of deaths per laboratory parameter range.
Measured: 1, 3, and 12 months
Treatment and Mortality Outcomes
Outcome Measure: Mortality rate stratified by type of treatment (e.g., medications, surgical interventions). Unit of Measure: Percentage (%) or number of deaths per treatment type.
Measured: 1, 3, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Jan 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of medicine, Maharagjung medical campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bibek Rajbhandari, Institute of medicine, Maharagjung medical campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560983
- Sponsor's protocol ID
- 6-11E2
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30871944Bender 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.
PubMed 29284999Lindsay 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.
PubMed 31658892Pandian 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.
PubMed 24396806Feigin 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.
PubMed 19233729Donkor 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.
PubMed 30598741Bates 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.
PubMed 24211696Mar 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.
PubMed 25889480Liljehult 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.
PubMed 32044222Goulart 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.
PubMed 21705233
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Mortality and Morbidity Outcome With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06560983
- Acronym / sponsor ID
- 6-11E2
- Conditions
- Cardiovascular Diseases
- Keywords
- Acute Stroke, Hyperglycemia, mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Institute of medicine, Maharagjung medical campusUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research design and methodology of this study are meticulously crafted to explore the complex interplay between acute stroke, hyperglycemia, and their impact on mortality and morbidity. This study adopts a prospective cohort design, following a systematic approach inspired by the Critical Appraisal Skills Programme (CASP) cohort study guidelines and adhering strictly to the STROBE (Strengthening the reporting of observational studies in epidemiology), reporting standards. By implementing a quantitative research method, the study aims to provide high-quality evidence through structured and transparent methodology.
The study focuses on individuals presenting with acute stroke in the Emergency Department (ED) of Tribhuvan University Teaching Hospital (TUTH). The high patient volume and the availability of advanced diagnostic tools like CT scans make TUTH's ED an ideal setting for this research. According to internal audits, TUTH's ED receives a significant number of acute stroke patients, ensuring a robust sample for the study. The study will specifically examine acute stroke patients with concurrent hyperglycemia, utilizing a systematic random sampling technique to ensure representative and unbiased selection. The sample size was calculated using proportions from previous international studies, with adjustments for potential loss to follow-up. The final sample size is set at 60 participants, evenly divided between those with hyperglycemia and those with normal glycemic levels, allowing for meaningful comparisons.
The study's dependent variables are mortality and morbidity, assessed at short-term (1 month), mid-term (3 months), and long-term (1 year) intervals. Independent variables include demographic characteristics, clinical history, and laboratory parameters. Matching based on age, sex, stroke type, and other relevant variables is essential to minimize confounding, enhancing the validity and reliability of the study's findings. Data collection will involve chart reviews for baseline characteristics and clinical history, followed by face-to-face interviews at 1 month, 3 months, and 1 year for follow-up assessments. Laboratory analyses will be conducted for blood glucose levels, and CT scans will be utilized to confirm stroke diagnoses and assess severity. Mortality will be tracked within specified time frames, while morbidity will be assessed using the Modified Rankin Score (MRS). Clinical variables such as vital signs, GCS score, and BEFAST criteria will be recorded meticulously. Hemorrhagic and ischemic strokes will be evaluated using specific criteria, including the The intracerebral hemorrhage (ICH) score and The NIH Stroke Scale/Score (NIHSS), respectively. Participants will be recruited through a systematic process at the triage registration desk, with initial assessments based on BEFAST criteria and additional clinical signs. Blood glucose levels will be measured, followed by CT imaging to confirm stroke diagnoses. This structured flow ensures the accurate identification of eligible participants and the collection of relevant data for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke with hyperglycemia | – | Other: The investigators are planning to do a observational cohort study, hence won't be doing any intervention.Exposed group signifies acute stroke presenting in emergency department with hyperglycemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients presenting with hypoglycemia
- Transient Ischemic Attack (TIA).
- Subdural hematoma cases.
- Subarachnoid hemorrhage cases.
- Diabetic Ketoacidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The investigators are planning to do a observational cohort study, hence won't be doing any intervention.The investigators won't be doing any intervention since this is an observational study. | Other | Acute stroke with hyperglycemia |
Primary outcome
Mortality outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
Time frame: 1, 3, and 12 months
Outcome Measure: Mortality rate among hyperglycemic patients with acute stroke. Unit of Measure: Percentage (%) or absolute number of deaths.
Morbidity outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
Time frame: 1, 3, and 12 months
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.
5 secondary outcomes
Demographic Characteristics and Mortality Outcomes
Time frame: 1, 3, and 12 months
Type of Stroke and Mortality Outcomes
Time frame: 1, 3, and 12 months
Clinical History and Mortality Outcomes
Time frame: 1, 3, and 12 months
Laboratory Parameters and Mortality Outcomes
Time frame: 1, 3, and 12 months
Treatment and Mortality Outcomes
Time frame: 1, 3, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 30871944GBD 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.
- Background: PubMed 29284999Bender 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.
- Background: PubMed 31658892Lindsay 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.
- Background: PubMed 24396806Pandian 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.
- Background: PubMed 19233729Feigin 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.
- Background: PubMed 30598741Donkor 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.
- Background: PubMed 24211696Bates 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.
- Background: PubMed 25889480Mar 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.
- Background: PubMed 32044222Liljehult 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.
- Background: PubMed 21705233Goulart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Institute of medicine, Maharagjung medical campus at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bibek Rajbhandari, masters (9851281884, bibekrajbhandarimg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality outcomes among hyperglycemic patients with acute stroke in the Emergency Department. (time frame: 1, 3, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560983, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.