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Clinical Trials/NCT05208424
NCT05208424
Completed
N/A

Incidence, Characteristics and Outcome of Patients With New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

Saud Al Babtain Cardiac Center1 site in 1 country300 target enrollmentFebruary 27, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Saud Al Babtain Cardiac Center
Enrollment
300
Locations
1
Primary Endpoint
Incidence
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 27, 2020
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Saud Al Babtain Cardiac Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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