Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat

Stroke Clinical Trial

Official title:

Factors of Control Hypertension or Non-insulin-dependent Diabetes Mellitus Type 2 on the Severity of Stroke and Survival Rates Within 1 Year in Trat Province.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06288269
• Other study ID #: PhrapokklaoHospital
• Status: Completed
• Start date: November 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: March 2024
• Source: Phrapokklao Hospital,Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled.

Description:

BACKGROUND: Situation of Non-communicable disease groups. It was the number one health problem in the world. The situation in Thailand from 2017-2022 found an increase in the number of new diagnoses and death cases from stroke patients. For the situation in Trat Province, it was found that the situation of sickness rates tend to be stable. As for the death rate per 100,000 people from stroke, there was a continuous upward trend. Therefore, a research project was organized to study the factors of control disease (hypertension or non-insulin-dependent diabetes mellitus type 2) on the severity of stroke and survival rates within 1 year to be used as information for further patient care.

OBJECTIVES: To study factors that influence the severity of stroke and correlate with survival rates within 1 year in Trat Province.

METHODS: This is a retrospective analytic cohort study. Data was collected using a Case Record Form (CRF) to record information on a total of 291 cases of hypertension and non-insulin-dependent diabetes mellitus type 2 patients who entered the stroke treatment system at Trat Hospital in the year 2022. Data were analyzed by Chi-square statistics to test the relationship of NCD control with the severity of stroke and using Kaplan-Meier Curve test hypotheses for comparing survival rates using Log-rank test statistics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 15, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients who have chronic hypertension or type 2 diabetes with a history of illness of at least 1 year before the stroke.

• Patients had a new stroke for the first time in his life, including an ischemic stroke. hemorrhagic stroke and hemorrhage in the brain

• The patient was confirmed by CT scan

• Thai nationality.

Exclusion Criteria:

• Patients diagnosed with cerebrovascular disease who have a previous history of ischemic or hemorrhagic stroke.

• Patients diagnosed with transient ischemic attack

• Patients who have a history of chronic disease that are at high risk of having a stroke, such as being a pregnant patient, still taking birth control pills.

• There are certain genetic diseases, such as antiphospholipid syndrome

• Patients had previous history of brain aneurysm, extracranial arterial dissection, atrial fibrillation, drug addict use, etc.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Stroke

Intervention

Other:
• Severity of Stroke and 1 year survival
Evaluated from NIHSS and clinical outcome 1 year survival death

Locations

Country	Name	City	State
Thailand	Trat Provincial Public Health Office	Trat

Sponsors (1)

Lead Sponsor	Collaborator
Phrapokklao Hospital,Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (12)

Alawneh KZ, Qawasmeh MA, Raffee LA, Al-Mistarehi AH. Ischemic stroke demographics, clinical features and scales and their correlations: an exploratory study from Jordan. Future Sci OA. 2022 Aug 5;8(7):FSO809. doi: 10.2144/fsoa-2022-0017. eCollection 2022 Aug. — View Citation

American Diabetes Association. Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers. Clin Diabetes. 2022 Jan;40(1):10-38. doi: 10.2337/cd22-as01. No abstract available. — View Citation

Chang WW, Fei SZ, Pan N, Yao YS, Jin YL. Incident Stroke and Its Influencing Factors in Patients With Type 2 Diabetes Mellitus and/or Hypertension: A Prospective Cohort Study. Front Cardiovasc Med. 2022 Feb 9;9:770025. doi: 10.3389/fcvm.2022.770025. eCollection 2022. — View Citation

Division of Noncommunicable Diseases DoDC, Ministry of Public Health,. Report on the situation of NCDs, diabetes, and high blood pressure. and related risk factors 2019. Akson Graphic and design Printing and Publishing 2019. 8-9 p.

Hu G, Sarti C, Jousilahti P, Peltonen M, Qiao Q, Antikainen R, Tuomilehto J. The impact of history of hypertension and type 2 diabetes at baseline on the incidence of stroke and stroke mortality. Stroke. 2005 Dec;36(12):2538-43. doi: 10.1161/01.STR.0000190894.30964.75. Epub 2005 Nov 10. — View Citation

Kandil H, Soliman A, Alghamdi NS, Jennings JR, El-Baz A. Using Mean Arterial Pressure in Hypertension Diagnosis versus Using Either Systolic or Diastolic Blood Pressure Measurements. Biomedicines. 2023 Mar 10;11(3):849. doi: 10.3390/biomedicines11030849. — View Citation

Kogan E, Twyman K, Heap J, Milentijevic D, Lin JH, Alberts M. Assessing stroke severity using electronic health record data: a machine learning approach. BMC Med Inform Decis Mak. 2020 Jan 8;20(1):8. doi: 10.1186/s12911-019-1010-x. — View Citation

Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6. — View Citation

Ntaios G, Egli M, Faouzi M, Michel P. J-shaped association between serum glucose and functional outcome in acute ischemic stroke. Stroke. 2010 Oct;41(10):2366-70. doi: 10.1161/STROKEAHA.110.592170. Epub 2010 Aug 19. — View Citation

Tziomalos K, Spanou M, Bouziana SD, Papadopoulou M, Giampatzis V, Kostaki S, Dourliou V, Tsopozidi M, Savopoulos C, Hatzitolios AI. Type 2 diabetes is associated with a worse functional outcome of ischemic stroke. World J Diabetes. 2014 Dec 15;5(6):939-44. doi: 10.4239/wjd.v5.i6.939. — View Citation

Vemmos KN, Tsivgoulis G, Spengos K, Zakopoulos N, Synetos A, Manios E, Konstantopoulou P, Mavrikakis M. U-shaped relationship between mortality and admission blood pressure in patients with acute stroke. J Intern Med. 2004 Feb;255(2):257-65. doi: 10.1046/j.1365-2796.2003.01291.x. — View Citation

Zhang X, Liu Y, Zhang F, Li J, Tong N. Legacy Effect of Intensive Blood Glucose Control on Cardiovascular Outcomes in Patients With Type 2 Diabetes and Very High Risk or Secondary Prevention of Cardiovascular Disease: A Meta-analysis of Randomized Controlled Trials. Clin Ther. 2018 May;40(5):776-788.e3. doi: 10.1016/j.clinthera.2018.03.015. Epub 2018 Apr 12. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42)	Patients with new stroke case with different diseases control will have different severity of stroke.	Results of controlling diabetes and hypertension in the 1-3 year period before having a stroke.
Primary	1 year survival death	Patients with new stroke case with different diseases control will have different death rate in 1 year	1 year after stroke attack

External Links

•   World Stroke Organization. WSO Global Stroke Fact Sheet 2022 [Internet]. 2022.