Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

Completed

• Conditions: Dysglycemia; Coronary Artery Disease
• Interventions: Radiation: Cardiac catheterization

• Registration Number: NCT05210972
• Lead Sponsor: Saud Al Babtain Cardiac Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Primary Completion: 2022-07-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

1. Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy.
2. Pregnant and post-partum patients (up to 3 months post-delivery).
3. Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72 m2).
4. Patients on any medications with glucose lowering effects.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal glycemia	Cardiac catheterization	HbA1c \<5.7% and FBG 110 mg/dL
Diabetes	Cardiac catheterization	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.
Prediabetes	Cardiac catheterization	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.

Primary Outcome Measures

Name	Time	Method
Coronary artery disease severity	1 day (During the hospital admission)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of HbA1c to CAD severity	1 day (During the hospital admission)	To correlate the level of HbA1c to the clinical and angiographic severity of CAD in the study populations

Trial Locations

Locations (1)

Saud Albatain cardiac Center; 🇸🇦 Dammam, Saudi Arabia