Acute Coronary Syndrome in Diabetic Patients

Sponsor

Faculty of Medicine, Tarumanagara University (Other)

Overall Status

Completed

CT.gov ID

NCT03607201

Collaborator

Cengkareng General Hospital (Other)

Enrollment

Location

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Diabetes Mellitus Heart Failure Acute Pulmonary Edema Cardiac Arrythmias	Other: No intervention

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 Design

Study Type:

Observational

Actual Enrollment :

86 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Diabetic History of diabetes prior to Acute Coronary Syndrome	Other: No intervention Routine care
Non-diabetic No documented history of diabetes prior to Acute Coronary Syndrome	Other: No intervention Routine care

Arm

Intervention/Treatment

Diabetic

History of diabetes prior to Acute Coronary Syndrome

Other: No intervention

Routine care

Non-diabetic

No documented history of diabetes prior to Acute Coronary Syndrome

Other: No intervention

Routine care

Outcome Measures

Primary Outcome Measures

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%.
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

Other Outcome Measures

GRACE Score [Through study completion, an average of 1 year]
GRACE (Global Registry of Acute Coronary Events) mortality risk score
TIMI Score [Through study completion, an average of 1 year]
Thrombolysis In Myocardial Infarction (TIMI) mortality risk score