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Completed

NCT Number: NCT05210972

Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Dysglycemia Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saud Albatain cardiac Center

Dammam, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac catheterization

Radiation

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

Primary outcomes

  1. Coronary artery disease severity

    Time frame: 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 outcomes

  1. Correlation of HbA1c to CAD severity

    Time frame: 1 day (During the hospital admission)

    To correlate the level of HbA1c to the clinical and angiographic severity of CAD in the study populations

Sponsors and collaborators

Lead sponsor

Saud Al Babtain Cardiac Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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