Impact of Prediabetes on Acute Coronary Syndrome

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

Study Overview

• Status: Completed
• Conditions: Diabetic Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with acute coronary syndrome; All patients with the acute coronary syndrome were included in the study. Pre-diabetic patient. Non-diabetic patient(Controlled)	Diagnostic test: Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
CCU admission	All patients admitted with acute coronary syndrome will be included in the research	6 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Amal K. Ahmed, Ass. Prof., Sohag University; Study Chair: Hany A. Muhammed Khalil, Lecturer, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 28, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Prediabetic State; Cardiomyopathies; Acute Coronary Syndrome; Diabetic Cardiomyopathies
• Other Study ID Numbers: Soh-Med-21-07-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No