Skip to main content
OpenTrials
Completed

NCT Number: NCT03607201

Acute Coronary Syndrome in Diabetic Patients

This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under International Classification of Disease (ICD-10) coding of I24.9 were included in this study. The inclusion criteria are patients with primary diagnosis of I24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. Participants were grouped into 2 groups - diabetic and non-diabetic based on history of diabetes prior to ACS. Diagnosis of ACS was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record.

Data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. Outcomes of interest were defined as either concomitant heart failure, acute lung edema, malignant arrhythmia, mortality or combinations of them as diagnosed in the medical records. Heart failure is defined based on echocardiographic findings from the medical records. Acute Lung Edema is defined based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%. Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia (VT) or ventricular fibrillation (VF).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on diabetes history

Exclusion criteria

  • Unavailability of electrocardiographic findings, cardiac marker results
  • Incomplete records of prior medical and treatment history

Treatment and study plan

No intervention

Other

Routine care

Primary outcomes

  1. Heart Failure

    Time frame: Through study completion, an average of 1 year

    Based on echocardiographic findings from the medical records

  2. Malignant Arrhythmia

    Time frame: Through study completion, an average of 1 year

    Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)

  3. Acute Lung Edema

    Time frame: Through study completion, an average of 1 year

    Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%.

  4. Cardiogenic Shock

    Time frame: Through study completion, an average of 1 year

    Clinical Diagnosis of Cardiogenic Shock reported in medical records

  5. Recurrent Myocardial Infarction

    Time frame: Through study completion, an average of 1 year

    Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

  6. Mortality

    Time frame: Through study completion, an average of 1 year

    Patient death reported in medical records

Other outcomes

  1. GRACE Score

    Time frame: Through study completion, an average of 1 year

    GRACE (Global Registry of Acute Coronary Events) mortality risk score

  2. TIMI Score

    Time frame: Through study completion, an average of 1 year

    Thrombolysis In Myocardial Infarction (TIMI) mortality risk score

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Cengkareng General Hospital

Registry information

Official study title

Comparing Clinical Profile and Outcomes of Acute Coronary Syndrome in Diabetic and Non-Diabetic Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2018
Registry last updated
Oct 16, 2018

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.

Published trials that share one or more normalized conditions with this study.