Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210972
• Other study ID #: SBCC-IRB-2021-06
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Saud Al Babtain Cardiac Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dysglycemia
• Myocardial Ischemia

Intervention

Radiation:
• Cardiac catheterization
All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.

Locations

Country	Name	City	State
Saudi Arabia	Saud Albatain cardiac Center	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Saud Al Babtain Cardiac Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)