Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

Study Overview
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Brief Summary
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This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.

Official Title
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Severity of Newly Diagnosed Coronary Artery Disease in Patients With Newly Diagnosed Diabetes and Pre-diabetes: A Cohort Study in a Cardiac Center in Saudi Arabia

Conditions
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Coronary Artery Disease, Dysglycemia

Intervention / Treatment
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* Radiation: Cardiac catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients with consents. First time diagnosis of CAD and no prior diagnosis of diabetes milletus (DM), or prediabetes. Coronary artery disease confirmed by invasive coronary angiography. Exclusion Criteria: Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy. Pregnant and post-partum patients (up to 3 months post-delivery). Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72 m2). Patients on any medications with glucose lowering effects.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes<br>Patients with level of HbA1c ≥ 6.5%, or Fasting blood glucose (FBG) ≥126 mg/dL, or a random plasma glucose (RBG) ≥ 200 mg/dL in a patient with classic symptoms of hyperglycemia. In the absence of unequivocal hyperglycemia, diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. | Radiation: Cardiac catheterization<br>* All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.<br>|
| Prediabetes<br>HbA1c 5.7-6.4% or FBG 110 mg/dL to 125 mg/dL The diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. | Radiation: Cardiac catheterization<br>* All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.<br>|
| Normal glycemia<br>HbA1c <5.7% and FBG 110 mg/dL | Radiation: Cardiac catheterization<br>* All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease severity | To measure how severe is the CAD, at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients. | 1 day (During the hospital admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of HbA1c to CAD severity | To correlate the level of HbA1c to the clinical and angiographic severity of CAD in the study populations | 1 day (During the hospital admission) |