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CompletedNCT03607201Updated Oct 16, 2018

Acute Coronary Syndrome in Diabetic Patients

An observational study in Acute Coronary Syndrome, Diabetes Mellitus and Heart Failure, sponsored by Tarumanagara University. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Tarumanagara University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
86
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

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

Keywords

  • acute coronary syndrome
  • diabetes
  • heart failure
  • acute pulmonary edema
  • malignant arrhythmia
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on diabetes history

Exclusion criteria

Exclusion Criteria:

  • Unavailability of electrocardiographic findings, cardiac marker results
  • Incomplete records of prior medical and treatment history
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • Diabetic

    History of diabetes prior to Acute Coronary Syndrome

    Other: No intervention

  • Non-diabetic

    No documented history of diabetes prior to Acute Coronary Syndrome

    Other: No intervention

Interventions

  • OtherNo intervention

    Routine care

05

What researchers measure

Primary outcomes

  1. Heart Failure

    Based on echocardiographic findings from the medical records

    Time frame: Through study completion, an average of 1 year

  2. Malignant Arrhythmia

    Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)

    Time frame: Through study completion, an average of 1 year

  3. 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%.

    Time frame: Through study completion, an average of 1 year

  4. Cardiogenic Shock

    Clinical Diagnosis of Cardiogenic Shock reported in medical records

    Time frame: Through study completion, an average of 1 year

  5. Recurrent Myocardial Infarction

    Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

    Time frame: Through study completion, an average of 1 year

  6. Mortality

    Patient death reported in medical records

    Time frame: Through study completion, an average of 1 year

Other outcomes

  1. GRACE Score

    GRACE (Global Registry of Acute Coronary Events) mortality risk score

    Time frame: Through study completion, an average of 1 year

  2. TIMI Score

    Thrombolysis In Myocardial Infarction (TIMI) mortality risk score

    Time frame: Through study completion, an average of 1 year

06

Study locations

1 site
  • Cengkareng General Hospital
    Jakarta, DKI Jakarta, Indonesia
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03607201
Lead sponsor
Tarumanagara University
Collaborators
Cengkareng General Hospital
Responsible party
Anthony Paulo Sunjaya (Principal Investigator, Tarumanagara University) — Principal investigator
First posted
Jul 31, 2018
Start date
Aug 1, 2017
Primary completion
Jun 30, 2018
Completion
Aug 31, 2018
Last update
Oct 16, 2018

Study contacts

Anthony P Sunjaya
principal investigator · Tarumanagara University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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