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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Arrhythmias, Cardiac; Acute Coronary Syndrome; Acute Pulmonary Edema
• Intervention / Treatment: Drug: Statins (Cardiovascular Agents)

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Cengkareng General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Statin; History of statin use prior to Acute Coronary Syndrome	Drug: Statins (Cardiovascular Agents); Prescribed with statins
Non-Statin; No documented history of statin use prior to Acute Coronary Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure	Based on echocardiographic findings from the medical records	Through study completion, an average of 1 year
Malignant Arrhythmia	Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)	Through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Tarumanagara University
• Collaborators: Cengkareng General Hospital
• Investigators: Study Chair: Andria Priyana, MD, FIHA, Department of Cardiology, Faculty of Medicine, Tarumanagara University; Principal Investigator: Angela F Sunjaya, Faculty of Medicine, Tarumanagara University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: acute coronary syndrome; heart failure; statin; acute pulmonary edema; malignant arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease; Heart Failure; Syndrome; Arrhythmias, Cardiac; Edema; Acute Coronary Syndrome; Pulmonary Edema
• Other Study ID Numbers: APS004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No