Primary Prevention With Statin and Incidence of Recurrent MI and Cardiogenic Shock in Post-ACS Patients

Completed

• Conditions: Recurrent Myocardial Infarction; Cardiogenic Shock; Acute Coronary Syndrome
• Interventions: Drug: Statin

• Registration Number: NCT03596944
• Lead Sponsor: Tarumanagara University

Brief Summary

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of recurrent myocardial infarction, cardiogenic shock and mortality 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 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 recurrent myocardial infarction, cardiogenic shock, mortality or combinations of them as diagnosed in the medical records. GRACE and TIMI Scores are calculated to predict in hospital and future mortality rates.

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: 145

Inclusion Criteria

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

Exclusion Criteria

• Unavailability of electrocardiographic findings, cardiac marker results, GRACE and TIMI score parameters
• Incomplete records of prior medical and treatment history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statin	Statin	History of statin use for primary prevention

Primary Outcome Measures

Name	Time	Method
Cardiogenic Shock	Through study completion, an average of 1 year	Clinical Diagnosis of Cardiogenic Shock reported in medical records
Mortality	Through study completion, an average of 1 year	Patient death 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

Trial Locations

Locations (1)

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