Clinical trial NCT03596944: Primary Prevention With Statin and Incidence of Recurrent MI and Cardiogenic Shock in Post-ACS Patients
Official title: Primary Prevention With Statin and Incidence of Recurrent Myocardial Infarction and Cardiogenic Shock in Post-Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Recurrent Myocardial Infarction
Cardiogenic Shock
Keywords: acute coronary syndrome
statin
mortality
GRACE score
TIMI score
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Cengkareng General Hospital
First posted: 2018-07-24
Enrollment: 145
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 International Classification of Diseases (ICD)10 coding of I24.9

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent Myocardial Infarction
timeFrame: Through study completion, an average of 1 year
measure: Cardiogenic Shock
timeFrame: Through study completion, an average of 1 year
measure: Mortality
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: GRACE Score
timeFrame: Through study completion, an average of 1 year
measure: TIMI Score
timeFrame: Through study completion, an average of 1 year
Locations:
city: Jakarta
country: Indonesia
facility: Cengkareng General Hospital
state: DKI Jakarta
Study officials:
affiliation: Tarumanagara University
name: Angela F Sunjaya
role: STUDY_CHAIR
affiliation: Tarumanagara University
name: Anthony P Sunjaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Faculty of Medicine, Tarumanagara University
name: Andria Priyana, MD, FIHA
role: PRINCIPAL_INVESTIGATOR
References: