Impact of Prediabetes on Acute Coronary Syndrome

NCT ID: NCT05102851

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-08-23

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

Conditions

Diabetic Cardiomyopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with acute coronary syndrome

All patients with the acute coronary syndrome were included in the study. Pre-diabetic patient. Non-diabetic patient(Controlled)

Troponin, Lipid profile, HBA1C, Fasting blood glucose level, Creatinine, Body Mass Index

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Dina Abdelnasser Elamir

Resident doctor at Internal Medicine department, Sohag University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal K. Ahmed, Ass. Prof.

Role: STUDY_DIRECTOR

Sohag University

Hany A. Muhammed Khalil, Lecturer

Role: STUDY_CHAIR

Sohag University

Locations

Sohag University

Sohag, , Egypt

Countries

Egypt

Other Identifiers

Soh-Med-21-07-05

Identifier Type: -

Identifier Source: org_study_id