NCT06288269

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

February 2, 2024

Last Update Submit

March 5, 2024

Conditions

Keywords

National Institute of Health Stroke Scale

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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

Study Arms (2)

Control of Hypertension or/and Type 2 Diabetic

Control disease of HT Control disease of DM2 Control disease of HT plus DM2

Other: Severity of Stroke and 1 year survival

Uncontrol of Hypertension or/and Type 2 Diabetic

Uncontrol disease of HT Uncontrol disease of DM2 Uncontrol disease of HT plus DM2

Other: Severity of Stroke and 1 year survival

Interventions

Evaluated from NIHSS and clinical outcome 1 year survival death

Control of Hypertension or/and Type 2 DiabeticUncontrol of Hypertension or/and Type 2 Diabetic

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A sample group of people who have had a stroke in fiscal year 2022 of people living in Trat Province. From the medical records center of Trat Hospital that received a diagnosis of stroke and were admitted to the hospital, a total of 729 cases were taken into the study process with criteria for selecting research participants (Inclusion criteria) and criteria. Exclusion criteria resulted in 291 patients who met the aforementioned criteria. There were 244 patients with hypertension as a comorbidity, 129 patients with type 2 diabetes as a comorbidity, and 100 patients with hypertension and type 2 diabetes as a comorbidity.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trat Provincial Public Health Office

Trat, 23000, Thailand

Location

Related Publications (12)

  • 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.

    BACKGROUND
  • 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.

    PMID: 31914991BACKGROUND
  • 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.

    PMID: 25512800BACKGROUND
  • 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.

    PMID: 36248068BACKGROUND
  • 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.

    PMID: 29656857BACKGROUND
  • 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.

    PMID: 14746563BACKGROUND
  • 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.

    PMID: 20724712BACKGROUND
  • 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.

    PMID: 16282538BACKGROUND
  • 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.

    PMID: 35224030BACKGROUND
  • 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.

    PMID: 32837228BACKGROUND
  • 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.

    PMID: 35221470BACKGROUND
  • 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.

    PMID: 36979828BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Panuwat Soponlertpong

    Trat Provincial Public Health Office

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Public Health Doctor of Trat Province

Study Record Dates

First Submitted

February 2, 2024

First Posted

March 1, 2024

Study Start

November 1, 2023

Primary Completion

December 30, 2023

Study Completion

January 15, 2024

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations