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Completed

NCT Number: NCT05208424

New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

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.

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Key information

Conditions

PreDiabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Prediabetic State Vascular Diseases

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saud AlBabtain Cardiac Center

Dammam, Saudi Arabia

Who can participate

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

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

Treatment and study plan

Coronary angiography

Diagnostic Test

Invasive coronary angiography

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Saud Al Babtain Cardiac Center

Other Gov

Registry information

Official study title

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

Acronym: DMCAD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 26, 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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