Impact of Prediabetes on Acute Coronary Syndrome

Diabetic Cardiomyopathy Clinical Trial

Official title:

Impact of Prediabetes On Acute Coronary Syndrome in Sohag University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102851
• Other study ID #: Soh-Med-21-07-05
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: August 23, 2022

Study information

• Verified date: July 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 23, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiomyopathies
• Diabetic Cardiomyopathies
• Diabetic Cardiomyopathy
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CCU admission	All patients admitted with acute coronary syndrome will be included in the research	6 months