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Acute Coronary Syndrome in Diabetic Patients

NCT03607201 — Completed, 86 participants, Tarumanagara University

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

RegistryNCT03607201
StatusCompleted
Study typeObservational
Enrollment86 (Actual)
SponsorTarumanagara University (Other); collaborators: Cengkareng General Hospital
ConditionsAcute Coronary Syndrome, Diabetes Mellitus, Heart Failure, Acute Pulmonary Edema, Cardiac Arrythmias
InterventionsNo intervention (Other)
Datesstart 2017-08-01, primary completion 2018-06-30, completion 2018-08-31, first posted 2018-07-31, last updated 2018-10-16
Locations1 site in Indonesia

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-Summary

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

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
DiabeticOther: No interventionHistory of diabetes prior to Acute Coronary Syndrome
Non-diabeticOther: No interventionNo documented history of diabetes prior to Acute Coronary Syndrome
  • No intervention (Other): Routine care

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
Cengkareng General HospitalJakarta, DKI JakartaIndonesia

+Investigators

My Notes