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

Completed

• Conditions: Diabetes; PreDiabetes; Coronary Artery Disease
• Interventions: Diagnostic Test: Coronary angiography

• Registration Number: NCT05208424
• Lead Sponsor: Saud Al Babtain Cardiac Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-27
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• 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: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes	Coronary angiography	100 patients without evidence diabetes defined as hemoglobin HbA1c \> 6.4% with or without FPG \>125 mg/dL.
Normal glycemia	Coronary angiography	100 patients without evidence of dysglycemia.
Prediabetes	Coronary angiography	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.

Primary Outcome Measures

Name	Time	Method
Incidence	Through study completion, an average of 2 year	The incidence, number and percent, of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease
Characteristics, clinical and laboratory	Through study completion, an average of 2 year	Clinical and laboratory characteristics of newly diagnosed diabetes and pre-diabetes in Patients with first-time diagnosed coronary artery disease.
Coronary artery disease severity	Through study completion, an average of 2 year	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.
Short-term outcome	From admission to 1-month follow up.	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.

Trial Locations

Locations (1)

Saud AlBabtain Cardiac Center; 🇸🇦 Dammam, Saudi Arabia