Diabetic CardiomyopathyNCT05102851
Impact of Prediabetes on Acute Coronary Syndrome
An observational study of Diabetic Cardiomyopathy, run by Sohag University at 1 site in Egypt.
Trial summary
Diabetes mellitus is one of the chronic non-communicable diseases which have emerged as a leading global health problem. According to the International Diabetes Federation Atlas guideline report, currently, there are 352 million adults with impaired glucose tolerance who are at high risk of developing diabetes in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Cardiomyopathy
- What is being tested?
- Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 23 Aug 2022
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Statistical presentation and analysis of the present study will be conducted SPSS V.22. Data will be expressed into phases: Ι- Descriptive Mean value(X) and Standard Deviation (SD): for quantitative data. Frequency and percentage for qualitative data. Π- Analytic by t-student test and Chi-square test. P value >0.05 will be considered statistically non-significant. P value ≤0.05 will be considered statistically significant. P value ≤0.001 will be considered statistically highly significant. Variance: Correlation of MPV with other parameters was performed by Pearson correlation test (r value as the coefficient).
Who may be able to join
- All patients with acute coronary syndrome
- Diabetic patients and will be subdivided into controlled and uncontrolled Pre-diabetic patients.
- Non-diabetic patient(Controlled)
Who cannot join
- Patient under 18 years old
- Pregnancy
- Chronic kidney disease
- Familiar hyperlipidemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prediabetes On Acute Coronary Syndrome in Sohag University Hospital
Diabetes mellitus is one of the chronic non-communicable diseases which have emerged as a leading global health problem. According to the International Diabetes Federation Atlas guideline report, currently, there are 352 million adults with impaired glucose tolerance who are at high risk of developing diabetes in the future. In 2017, it was estimated that 425 million people (20-79 years of age) suffered from Diabetes mellitus, and the number is expected to rise to 629 million by 2045. Moreover, Egypt is considered one of the top 10 countries in the world
Read the detailed description
Acute Coronary Syndrome refers to a constellation of symptoms compatible with acute myocardial ischemia. The syndrome includes systolic time segment elevation myocardial infarction non-systolic time segment elevation myocardial infarction and unstable angina.
Patients have an over tenfold risk for cardiovascular disease in their lifetime. In the United States, 77% of diabetes-related hospital admissions are for cardiovascular complications. A key feature of diabetes contributing to this is the development of accelerated atherosclerosis.
Prediabetes is a collective term that encloses individuals with glucose levels lower than cutoff levels for diabetes but too high to be considered normal. Fasting blood glucose 6.1 mmol/L- <7.0 mmol/L. In impaired glucose tolerance the ranges of blood glucose are>7.8 mmol/L-<11.1 mmol/L4.
Prediabetes is associated with a significant increase in cardiovascular morbidity and mortality and necessitates early and adequate intervention to prevent the development of complications, and progression to overt diabetes.
Higher fasting glucose levels in patients with the acute coronary syndrome were associated with worse clinical outcomes irrespective of the presence of diabetes mellitus. Similarly, higher fasting glucose was a marker of adverse outcomes in patients without diabetes presenting with acute systolic time segment elevation myocardial infarction.
Impaired glucose tolerance is common among non-diabetic patients admitted with the acute coronary syndrome. However, evidence is controversial regarding the prognostic impact of 'prediabetes' on the clinical outcome
- Conditions
- Diabetic Cardiomyopathy
- Being tested
- Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass IndexDiagnostic test
Full history: age, sex, smoking, known diabetes, positive family history high serum creatinine, history of prior percutaneous coronary intervention (PCI) or coronary arteries bypass grafting (CABG), or acute coronary syndrome (ACS). hypertension, diet.
| Study group | Role | What they receive |
|---|---|---|
| Patient with acute coronary syndrome | All patients with the acute coronary syndrome were included in the study. Pre-diabetic patient. Non-diabetic patient(Controlled) Receives: Diagnostic Test: Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hba1c
We consider patients with Hba1c less than 5.7% not diabetic , Patients with Hba1c from 5.7%-6.4% prediabetic and patients with Hba1c 6.5% or more diabetic patients
Measured: Day 1
CCU admission
All patients admitted with acute coronary syndrome will be included in the research
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdelnasser Elamir, Sohag University
- Investigators
- Amal K. Ahmed, Ass. Prof., Study director, Sohag UniversityHany A. Muhammed Khalil, Lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102851
- Sponsor's protocol ID
- Soh-Med-21-07-05
- Status last verified
- Jul 2021
- First submitted
- 18 Aug 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prediabetes On Acute Coronary Syndrome in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05102851
- Acronym / sponsor ID
- Soh-Med-21-07-05
- Conditions
- Diabetic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 2 Nov 2021 (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.
Diabetes mellitus is one of the chronic non-communicable diseases which have emerged as a leading global health problem. According to the International Diabetes Federation Atlas guideline report, currently, there are 352 million adults with impaired glucose tolerance who are at high risk of developing diabetes in the future. In 2017, it was estimated that 425 million people (20-79 years of age) suffered from Diabetes mellitus, and the number is expected to rise to 629 million by 2045. Moreover, Egypt is considered one of the top 10 countries in the world
Detailed description
Acute Coronary Syndrome refers to a constellation of symptoms compatible with acute myocardial ischemia. The syndrome includes systolic time segment elevation myocardial infarction non-systolic time segment elevation myocardial infarction and unstable angina.
Patients have an over tenfold risk for cardiovascular disease in their lifetime. In the United States, 77% of diabetes-related hospital admissions are for cardiovascular complications. A key feature of diabetes contributing to this is the development of accelerated atherosclerosis.
Prediabetes is a collective term that encloses individuals with glucose levels lower than cutoff levels for diabetes but too high to be considered normal. Fasting blood glucose 6.1 mmol/L- <7.0 mmol/L. In impaired glucose tolerance the ranges of blood glucose are>7.8 mmol/L-<11.1 mmol/L4.
Prediabetes is associated with a significant increase in cardiovascular morbidity and mortality and necessitates early and adequate intervention to prevent the development of complications, and progression to overt diabetes.
Higher fasting glucose levels in patients with the acute coronary syndrome were associated with worse clinical outcomes irrespective of the presence of diabetes mellitus. Similarly, higher fasting glucose was a marker of adverse outcomes in patients without diabetes presenting with acute systolic time segment elevation myocardial infarction.
Impaired glucose tolerance is common among non-diabetic patients admitted with the acute coronary syndrome. However, evidence is controversial regarding the prognostic impact of 'prediabetes' on the clinical outcome
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with acute coronary syndrome | – | Diagnostic Test: Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass IndexAll patients with the acute coronary syndrome were included in the study. Pre-diabetic patient. Non-diabetic patient(Controlled) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Statistical presentation and analysis of the present study will be conducted SPSS V.22. Data will be expressed into phases: Ι- Descriptive Mean value(X) and Standard Deviation (SD): for quantitative data. Frequency and percentage for qualitative data. Π- Analytic by t-student test and Chi-square test. P value >0.05 will be considered statistically non-significant. P value ≤0.05 will be considered statistically significant. P value ≤0.001 will be considered statistically highly significant. Variance: Correlation of MPV with other parameters was performed by Pearson correlation test (r value as the coefficient).
Key inclusion criteria (3 listed)
- All patients with acute coronary syndrome
- Diabetic patients and will be subdivided into controlled and uncontrolled Pre-diabetic patients.
- Non-diabetic patient(Controlled)
Key exclusion criteria (4 listed)
- Patient under 18 years old
- Pregnancy
- Chronic kidney disease
- Familiar hyperlipidemia.
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 |
|---|---|---|
| Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass IndexFull history: age, sex, smoking, known diabetes, positive family history high serum creatinine, history of prior percutaneous coronary intervention (PCI) or coronary arteries bypass grafting (CABG), or acute coronary syndrome (ACS). hypertension, diet. | Diagnostic test | Patient with acute coronary syndrome |
Primary outcome
Hba1c
Time frame: Day 1
We consider patients with Hba1c less than 5.7% not diabetic , Patients with Hba1c from 5.7%-6.4% prediabetic and patients with Hba1c 6.5% or more diabetic patients
CCU admission
Time frame: 6 months
All patients admitted with acute coronary syndrome will be included in the research
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 31 Aug 2022.
- 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.
Amal K. Ahmed, Ass. Prof. study director
Sohag University
Hany A. Muhammed Khalil, Lecturer study chair
Sohag University
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 Diabetic Cardiomyopathy, run by Sohag University at 1 site in Egypt.
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 4 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 31 Aug 2022. 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 Egypt. 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?
Hba1c (time frame: Day 1). 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?
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 31 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.