Acute Coronary Syndrome in Diabetic Patients

October 13, 2018 updated by: Anthony Paulo Sunjaya, Tarumanagara University

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic
History of diabetes prior to Acute Coronary Syndrome
Routine care
Non-diabetic
No documented history of diabetes prior to Acute Coronary Syndrome
Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure
Time Frame: Through study completion, an average of 1 year
Based on echocardiographic findings from the medical records
Through study completion, an average of 1 year
Malignant Arrhythmia
Time Frame: Through study completion, an average of 1 year
Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)
Through study completion, an average of 1 year
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%.
Through study completion, an average of 1 year
Recurrent Myocardial Infarction
Time Frame: Through study completion, an average of 1 year
Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records
Through study completion, an average of 1 year
Cardiogenic Shock
Time Frame: Through study completion, an average of 1 year
Clinical Diagnosis of Cardiogenic Shock reported in medical records
Through study completion, an average of 1 year
Mortality
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
GRACE (Global Registry of Acute Coronary Events) mortality risk score
Through study completion, an average of 1 year
TIMI Score
Time Frame: Through study completion, an average of 1 year
Thrombolysis In Myocardial Infarction (TIMI) mortality risk score
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony P Sunjaya, Tarumanagara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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