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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596944
• Other study ID #: APS005
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Faculty of Medicine, Tarumanagara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Recurrent Myocardial Infarction
• Shock
• Shock, Cardiogenic
• Syndrome

Intervention

Drug:
• Statin
Prescribed with statins for primary prevention

Locations

Country	Name	City	State
Indonesia	Cengkareng General Hospital	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, Tarumanagara University	Department of Cardiology, Cengkareng General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GRACE Score	GRACE (Global Registry of Acute Coronary Events) mortality risk score	Through study completion, an average of 1 year
Other	TIMI Score	Thrombolysis In Myocardial Infarction (TIMI) mortality risk score	Through study completion, an average of 1 year
Primary	Recurrent Myocardial Infarction	Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records	Through study completion, an average of 1 year
Primary	Cardiogenic Shock	Clinical Diagnosis of Cardiogenic Shock reported in medical records	Through study completion, an average of 1 year
Primary	Mortality	Patient death reported in medical records	Through study completion, an average of 1 year