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

Completed

• Conditions: Acute Coronary Syndrome; Arrhythmias, Cardiac; Acute Pulmonary Edema; Heart Failure
• Interventions: Drug: Statins (Cardiovascular Agents)

• Registration Number: NCT03596931
• Lead Sponsor: Tarumanagara University

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).

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-06-30
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statin	Statins (Cardiovascular Agents)	History of statin use prior to Acute Coronary Syndrome

Primary Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (1)

Cengkareng General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia