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

Primary Prevention With Statin and Incidence of Recurrent Myocardial Infarction and Cardiogenic Shock in Post-Acute Coronary Syndrome Patients

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Cardiogenic Shock; Recurrent Myocardial Infarction
• Intervention / Treatment: Drug: Statin

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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Cengkareng General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under International Classification of Diseases (ICD)10 coding of I24.9

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Statin; No documented history of statin use prior to Acute Coronary Syndrome
Statin; History of statin use for primary prevention	Drug: Statin; Prescribed with statins for primary prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Myocardial Infarction	Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records	Through study completion, an average of 1 year
Cardiogenic Shock	Clinical Diagnosis of Cardiogenic Shock reported in medical records	Through study completion, an average of 1 year
Mortality	Patient death reported in medical records	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRACE Score	GRACE (Global Registry of Acute Coronary Events) mortality risk score	Through study completion, an average of 1 year
TIMI Score	Thrombolysis In Myocardial Infarction (TIMI) mortality risk score	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Tarumanagara University
• Collaborators: Cengkareng General Hospital
• Investigators: Study Chair: Angela F Sunjaya, Faculty of Medicine, Tarumanagara University; Principal Investigator: Andria Priyana, MD, FIHA, Department of Cardiology, Faculty of Medicine, Tarumanagara University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: acute coronary syndrome; mortality; TIMI score; statin; GRACE score
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Disease; Myocardial Infarction; Infarction; Syndrome; Recurrence; Shock; Acute Coronary Syndrome; Shock, Cardiogenic
• Other Study ID Numbers: APS005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No