Acute Coronary Syndrome in Diabetic Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607201
• Other study ID #: APS006
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: Faculty of Medicine, Tarumanagara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Pulmonary Edema
• Arrhythmias, Cardiac
• Cardiac Arrythmias
• Diabetes Mellitus
• Heart Failure
• Pulmonary Edema
• Syndrome

Intervention

Other:
• No intervention
Routine care

Locations

Country	Name	City	State
Indonesia	Cengkareng General Hospital	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, Tarumanagara University	Department of Cardiology, Cengkareng General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GRACE Score	GRACE (Global Registry of Acute Coronary Events) mortality risk score	Through study completion, an average of 1 year
Other	TIMI Score	Thrombolysis In Myocardial Infarction (TIMI) mortality risk score	Through study completion, an average of 1 year
Primary	Heart Failure	Based on echocardiographic findings from the medical records	Through study completion, an average of 1 year
Primary	Malignant Arrhythmia	Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)	Through study completion, an average of 1 year
Primary	Acute Lung Edema	Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%.	Through study completion, an average of 1 year
Primary	Cardiogenic Shock	Clinical Diagnosis of Cardiogenic Shock reported in medical records	Through study completion, an average of 1 year
Primary	Recurrent Myocardial Infarction	Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records	Through study completion, an average of 1 year
Primary	Mortality	Patient death reported in medical records	Through study completion, an average of 1 year