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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03596944
Other study ID # APS005
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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