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

Heart Failure Clinical Trial

Official title:

Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596931
• Other study ID #: APS004
• 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 heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• 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:

• History of heart failure, acute lung edema and arrhythmia

• Unavailability of electrocardiographic findings, cardiac marker results

• Incomplete records of prior medical and treatment history

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Pulmonary Edema
• Arrhythmias, Cardiac
• Edema
• Heart Failure
• Pulmonary Edema
• Syndrome

Intervention

Drug:
• Statins (Cardiovascular Agents)
Prescribed with statins

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
Primary	Heart Failure	Based on echocardiographic findings from the medical records	Through study completion, an average of 1 year
Primary	Malignant Arrhythmia	Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)	Through study completion, an average of 1 year
Primary	Acute Lung Edema	Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%.	Through study completion, an average of 1 year