StrokeNCT06288269
Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat
An observational study of Stroke and Hypertension, run by Phrapokklao Hospital,Thailand at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Hypertension, Type2diabetes
- What is being tested?
- Severity of Stroke and 1 year survival
- How many people
- 291 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed 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.
- Conditions
- Stroke, Hypertension, Type2diabetes
- Being tested
- Severity of Stroke and 1 year survival
- Keywords
- National Institute of Health Stroke Scale
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severity of Stroke and 1 year survivalOther
Evaluated from NIHSS and clinical outcome 1 year survival death
| Study group | Role | What they receive |
|---|---|---|
| Control of Hypertension or/and Type 2 Diabetic | Control disease of HT Control disease of DM2 Control disease of HT plus DM2 Receives: 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 Receives: Other: Severity of Stroke and 1 year survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year after stroke attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Nov 2023
- Primary completion30 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Retrospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phrapokklao Hospital,Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panuwat Soponlertpong, Phrapokklao Hospital,Thailand
- Investigators
- Panuwat Soponlertpong, Principal investigator, Trat Provincial Public Health Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288269
- Sponsor's protocol ID
- PhrapokklaoHospital
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 31914991Tziomalos 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.
PubMed 25512800Alawneh 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.
PubMed 36248068Zhang 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.
PubMed 29656857Vemmos 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.
PubMed 14746563Ntaios 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.
PubMed 20724712Hu 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.
PubMed 16282538Chang 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.
PubMed 35224030Murphy 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.
PubMed 32837228American 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.
PubMed 35221470Kandil 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.
PubMed 36979828
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06288269
- Acronym / sponsor ID
- PhrapokklaoHospital
- Conditions
- Stroke, Hypertension, Type2diabetes
- Keywords
- National Institute of Health Stroke Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Phrapokklao Hospital,ThailandUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Mar 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control of Hypertension or/and Type 2 Diabetic | – | Other: Severity of Stroke and 1 year survivalControl disease of HT Control disease of DM2 Control disease of HT plus DM2 |
| Uncontrol of Hypertension or/and Type 2 Diabetic | – | Other: Severity of Stroke and 1 year survivalUncontrol disease of HT Uncontrol disease of DM2 Uncontrol disease of HT plus DM2 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Severity of Stroke and 1 year survivalEvaluated from NIHSS and clinical outcome 1 year survival death | Other | Control of Hypertension or/and Type 2 Diabetic, Uncontrol of Hypertension or/and Type 2 Diabetic |
Primary outcome
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)
Time frame: Results of controlling diabetes and hypertension in the 1-3 year period before having a stroke.
Patients with new stroke case with different diseases control will have different severity of stroke.
1 year survival death
Time frame: 1 year after stroke attack
Patients with new stroke case with different diseases control will have different death rate in 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- BackgroundDivision 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: PubMed 31914991Kogan 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.
- Background: PubMed 25512800Tziomalos 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.
- Background: PubMed 36248068Alawneh 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.
- Background: PubMed 29656857Zhang 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.
- Background: PubMed 14746563Vemmos 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.
- Background: PubMed 20724712Ntaios 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.
- Background: PubMed 16282538Hu 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.
- Background: PubMed 35224030Chang 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.
- Background: PubMed 32837228Murphy 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.
- Background: PubMed 35221470American 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.
- Background: PubMed 36979828Kandil 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.
- World Stroke Organization. WSO Global Stroke Fact Sheet 2022 \[Internet\]. 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Panuwat Soponlertpong principal investigator
Trat Provincial Public Health Office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hypertension, run by Phrapokklao Hospital,Thailand at 1 site in Thailand.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Results of controlling diabetes and hypertension in the 1-3 year period before having a stroke.). 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 NCT06288269, which also lists 12 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 7 Mar 2024.