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Clinical Trials/NCT03607201
NCT03607201
Completed
Not Applicable

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

Tarumanagara University1 site in 1 country86 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Tarumanagara University
Enrollment
86
Locations
1
Primary Endpoint
Cardiogenic Shock
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
August 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tarumanagara University
Responsible Party
Principal Investigator
Principal Investigator

Anthony Paulo Sunjaya

Principal Investigator

Tarumanagara University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiogenic Shock

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

Clinical Diagnosis of Cardiogenic Shock reported in medical records

Recurrent Myocardial Infarction

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

Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

Mortality

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

Patient death reported in medical records

Heart Failure

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

Based on echocardiographic findings from the medical records

Malignant Arrhythmia

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

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

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%.

Study Sites (1)

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