Acute Coronary Syndrome in Diabetic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes Mellitus; Acute Coronary Syndrome; Cardiac Arrythmias; Acute Pulmonary Edema
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Cengkareng General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure	Based on echocardiographic findings from the medical records	Through study completion, an average of 1 year
Malignant Arrhythmia	Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)	Through study completion, an average of 1 year
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
Recurrent Myocardial Infarction	Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records	Through study completion, an average of 1 year
Cardiogenic Shock	Clinical Diagnosis of Cardiogenic Shock reported in medical records	Through study completion, an average of 1 year
Mortality	Patient death reported in medical records	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRACE Score	GRACE (Global Registry of Acute Coronary Events) mortality risk score	Through study completion, an average of 1 year
TIMI Score	Thrombolysis In Myocardial Infarction (TIMI) mortality risk score	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Tarumanagara University
• Collaborators: Cengkareng General Hospital
• Investigators: Principal Investigator: Anthony P Sunjaya, Tarumanagara University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 13, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; acute coronary syndrome; heart failure; acute pulmonary edema; malignant arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease; Heart Failure; Syndrome; Arrhythmias, Cardiac; Acute Coronary Syndrome; Pulmonary Edema
• Other Study ID Numbers: APS006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No