Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

Sponsor

Saud Al Babtain Cardiac Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05210972

Collaborator

(none)

150

Enrollment

Location

12.9

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Dysglycemia	Radiation: Cardiac catheterization

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saud Albatain cardiac Center	Dammam		Saudi Arabia

Sponsors and Collaborators

Saud Al Babtain Cardiac Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saud Al Babtain Cardiac Center

ClinicalTrials.gov Identifier:

NCT05210972

Other Study ID Numbers:

SBCC-IRB-2021-06

First Posted:

Jan 27, 2022

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Jan 27, 2022