Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Dysglycemia
• Intervention / Treatment: Radiation: Cardiac catheterization

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia
    • Saud Albatain cardiac Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A single center cohort study, where all comers, adult patients without prior diagnosis of DM, who are admitted with a first-time diagnosis of CAD, as confirmed by invasive coronary angiography, either elective or as emergency, will be eligible. The study will prospectively enroll consecutives and contemporary cases for each group of diabetes, pre-diabetes and normal glycemia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes; 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; All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.
Prediabetes; 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; All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.
Normal glycemia; HbA1c <5.7% and FBG 110 mg/dL	Radiation: Cardiac catheterization; All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Saud Al Babtain Cardiac Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SBCC-IRB-2021-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No