Clinical trial NCT05102851: Impact of Prediabetes on Acute Coronary Syndrome
Official title: Impact of Prediabetes On Acute Coronary Syndrome in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Cardiomyopathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* All patients with acute coronary syndrome
* Diabetic patients and will be subdivided into controlled and uncontrolled Pre-diabetic patients.
* Non-diabetic patient(Controlled)

Exclusion Criteria:

* Patient under 18 years old
* Pregnancy
* Chronic kidney disease
* Familiar hyperlipidemia.

Primary outcomes:
measure: Hba1c
timeFrame: Day 1
measure: CCU admission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Amal K. Ahmed, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Hany A. Muhammed Khalil, Lecturer
role: STUDY_CHAIR
References: