Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

NCT ID: NCT03596931

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-08-31

Brief Summary

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This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

Detailed Description

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Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 without a prior history of heart failure, acute lung edema and arrhythmia 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 concomitant heart failure, acute lung edema, malignant arrhythmia, mortality or combinations of them as diagnosed in the medical records. Heart failure is defined based on echocardiographic findings from the medical records. Acute Lung Edema is defined based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation \<90%. Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia (VT) or ventricular fibrillation (VF).

Conditions

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Acute Coronary Syndrome Acute Pulmonary Edema Arrhythmias, Cardiac Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Statin

History of statin use prior to Acute Coronary Syndrome

Statins (Cardiovascular Agents)

Intervention Type DRUG

Prescribed with statins

Non-Statin

No documented history of statin use prior to Acute Coronary Syndrome

No interventions assigned to this group

Interventions

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Statins (Cardiovascular Agents)

Prescribed with statins

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of heart failure, acute lung edema and arrhythmia
* Unavailability of electrocardiographic findings, cardiac marker results
* Incomplete records of prior medical and treatment history
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cengkareng General Hospital

OTHER

Sponsor Role collaborator

Tarumanagara University

OTHER

Sponsor Role lead

Responsible Party

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Angela Felicia Sunjaya

Co Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andria Priyana, MD, FIHA

Role: STUDY_CHAIR

Department of Cardiology, Faculty of Medicine, Tarumanagara University

Angela F Sunjaya

Role: PRINCIPAL_INVESTIGATOR

Tarumanagara University

Anthony P Sunjaya

Role: PRINCIPAL_INVESTIGATOR

Tarumanagara University

Locations

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Cengkareng General Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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APS004

Identifier Type: -

Identifier Source: org_study_id

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