New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

Study Overview
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Brief Summary
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A prospective analytic study to evaluate the incidence, clinical and laboratory characteristics, extent of coronary artery disease and short-term outcome of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease treated in Saud Al Babtain Cardiac Center.

Official Title
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Incidence, Characteristics and Outcome of Patients With New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

Conditions
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PreDiabetes, Diabetes, Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Coronary angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time diagnosed coronary artery disease as confirmed by invasive coronary angiography Emergently or electively admitted as coronary artery disease patients. Informed consent form Exclusion Criteria: Prior diagnosis of diabetes or pre-diabetes based on the diagnostic criteria of the American Diabetes Association (ADA, 2020) Known coronary artery disease

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal glycemia<br>100 patients without evidence of dysglycemia. | Diagnostic Test: Coronary angiography<br>* Invasive coronary angiography<br>|
| Prediabetes<br>100 patients with evidence of pre-diabetes defined as hemoglobin A1C (HbA1c) 5.7-6.4% with or without fasting plasma glucose (FPG) of 100 mg/dL to 125 mg/dL. | Diagnostic Test: Coronary angiography<br>* Invasive coronary angiography<br>|
| Diabetes<br>100 patients without evidence diabetes defined as hemoglobin HbA1c > 6.4% with or without FPG >125 mg/dL. | Diagnostic Test: Coronary angiography<br>* Invasive coronary angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | The incidence, number and percent, of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease | Through study completion, an average of 2 year | 
| Characteristics, clinical and laboratory | Clinical and laboratory characteristics of newly diagnosed diabetes and pre-diabetes in Patients with first-time diagnosed coronary artery disease. | Through study completion, an average of 2 year | 
| Coronary artery disease severity | Extent of newly diagnosed coronary artery disease in newly diagnosed diabetes and pre-diabetes. The severity of coronary artery disease will be assessed using the SYNTAX score. | Through study completion, an average of 2 year | 
| Short-term outcome | Assessment will include in-hospital and 1-month major adverse cardiac events (MACE), recurrent angina, stent thrombosis, need for emergent/urgent coronary intervention, clinical heart failure and left ventricular dysfunction. | From admission to 1-month follow up. |