Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

NCT05210972 | Completed DMC

• 1 other identifier: SBCC-IRB-2021-06
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Dysglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of HbA1c to CAD severity

  1 day (During the hospital admission)

Study Arms (3)

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

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

Normal glycemia

HbA1c \<5.7% and FBG 110 mg/dL

Radiation: Cardiac catheterization

Interventions

Cardiac catheterization RADIATION

All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.

Diabetes; Normal glycemia; Prediabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saud Al Babtain Cardiac Center: lead

Study Sites (1)

Saud Albatain cardiac Center

Dammam, Saudi Arabia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 27, 2022
• Study Start: July 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)