Clinical trial NCT03596931: Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
Official title: Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Acute Pulmonary Edema
Arrhythmias, Cardiac
Heart Failure
Keywords: acute coronary syndrome
statin
acute pulmonary edema
malignant arrhythmia
heart failure
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Cengkareng General Hospital
First posted: 2018-07-24
Enrollment: 130
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 without a prior history of heart failure, acute lung edema and arrhythmia.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

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
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cengkareng General Hospital
state: DKI Jakarta
Study officials:
affiliation: Department of Cardiology, Faculty of Medicine, Tarumanagara University
name: Andria Priyana, MD, FIHA
role: STUDY_CHAIR
affiliation: Tarumanagara University
name: Angela F Sunjaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarumanagara University
name: Anthony P Sunjaya
role: PRINCIPAL_INVESTIGATOR
References: