Impact of Prediabetes on Acute Coronary Syndrome

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05102851

Collaborator

(none)

Enrollment

Location

8.6

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Cardiomyopathy	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Prediabetes On Acute Coronary Syndrome in Sohag University Hospital

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Hba1c [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 [6 months]
All patients admitted with acute coronary syndrome will be included in the research

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82524

Sponsors and Collaborators

Sohag University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina Abdelnasser Elamir, Resident doctor at Internal Medicine department, Sohag University Hospital, Sohag University

ClinicalTrials.gov Identifier:

NCT05102851

Other Study ID Numbers:

Soh-Med-21-07-05

First Posted:

Nov 2, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Coronary Syndrome

Cardiomyopathies

Diabetic Cardiomyopathies

Prediabetic State

Study Results

No Results Posted as of Nov 2, 2021