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

NCT03596931 | Completed

• 1 other identifier: APS004
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

acute coronary syndrome; statin; acute pulmonary edema; malignant arrhythmia; heart failure

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Statin

History of statin use prior to Acute Coronary Syndrome

Drug: Statins (Cardiovascular Agents)

Non-Statin

No documented history of statin use prior to Acute Coronary Syndrome

Interventions

Statins (Cardiovascular Agents) DRUG

Prescribed with statins

Statin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tarumanagara University: lead
• Cengkareng General Hospital: collaborator

Study Sites (1)

Cengkareng General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Arrhythmias, Cardiac; Heart Failure

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Cardiovascular Agents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Andria Priyana, MD, FIHA

  Department of Cardiology, Faculty of Medicine, Tarumanagara University

  STUDY CHAIR

• Angela F Sunjaya

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

• Anthony P Sunjaya

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co Principal Investigator

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: August 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 31, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

ID (1)