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OpenTrials
Completed

NCT Number: NCT03596931

Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cengkareng General Hospital

Jakarta, DKI Jakarta, Indonesia

About this study

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 without a prior history of heart failure, acute lung edema and arrhythmia 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 - statin and non-statin based on prior history of statin use 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on statin prescription history

Exclusion criteria

  • History of heart failure, acute lung edema and arrhythmia
  • Unavailability of electrocardiographic findings, cardiac marker results
  • Incomplete records of prior medical and treatment history

Treatment and study plan

Statins (Cardiovascular Agents)

Drug

Prescribed with statins

Primary outcomes

  1. Heart Failure

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

    Based on echocardiographic findings from the medical records

  2. Malignant Arrhythmia

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

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

  3. 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%.

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Cengkareng General Hospital

Registry information

Official study title

Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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