Clinical trial NCT03607201: Acute Coronary Syndrome in Diabetic Patients
Official title: Comparing Clinical Profile and Outcomes of Acute Coronary Syndrome in Diabetic and Non-Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Diabetes Mellitus
Heart Failure
Acute Pulmonary Edema
Cardiac Arrythmias
Keywords: acute coronary syndrome
diabetes
heart failure
acute pulmonary edema
malignant arrhythmia
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Cengkareng General Hospital
First posted: 2018-07-31
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Heart Failure
timeFrame: Through study completion, an average of 1 year
measure: Malignant Arrhythmia
timeFrame: Through study completion, an average of 1 year
measure: Acute Lung Edema
timeFrame: Through study completion, an average of 1 year
measure: Cardiogenic Shock
timeFrame: Through study completion, an average of 1 year
measure: Recurrent Myocardial Infarction
timeFrame: Through study completion, an average of 1 year
measure: Mortality
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: GRACE Score
timeFrame: Through study completion, an average of 1 year
measure: TIMI Score
timeFrame: Through study completion, an average of 1 year
Locations:
city: Jakarta
country: Indonesia
facility: Cengkareng General Hospital
state: DKI Jakarta
Study officials:
affiliation: Tarumanagara University
name: Anthony P Sunjaya
role: PRINCIPAL_INVESTIGATOR
References: