Acute Coronary Syndrome in Diabetic Patients

Completed

• Conditions: Acute Coronary Syndrome; Diabetes Mellitus; Acute Pulmonary Edema; Heart Failure; Cardiac Arrythmias
• Interventions: Other: No intervention

• Registration Number: NCT03607201
• Lead Sponsor: Tarumanagara University

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).

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-06-30
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Completion: 2018-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-13
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-diabetic	No intervention	No documented history of diabetes prior to Acute Coronary Syndrome
Diabetic	No intervention	History of diabetes prior to Acute Coronary Syndrome

Primary Outcome Measures

Name	Time	Method
Cardiogenic Shock	Through study completion, an average of 1 year	Clinical Diagnosis of Cardiogenic Shock reported in medical records
Recurrent Myocardial Infarction	Through study completion, an average of 1 year	Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records
Mortality	Through study completion, an average of 1 year	Patient death reported in medical records
Heart Failure	Through study completion, an average of 1 year	Based on echocardiographic findings from the medical records
Malignant Arrhythmia	Through study completion, an average of 1 year	Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)
Acute Lung Edema	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%.

Trial Locations

Locations (1)

Cengkareng General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia