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

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ClinicalTrials.gov Identifier: NCT03596931
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Cengkareng General Hospital
Information provided by (Responsible Party):
Angela Felicia Sunjaya, Faculty of Medicine, Tarumanagara University

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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Acute Pulmonary Edema Arrhythmias, Cardiac Heart Failure 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).


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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Heart Failure [ Time Frame: Through study completion, an average of 1 year ]
    Based on echocardiographic findings from the medical records

  2. Malignant Arrhythmia [ Time Frame: Through study completion, an average of 1 year ]
    Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)

  3. Acute Lung Edema [ Time Frame: Through study completion, an average of 1 year ]
    Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596931


Locations
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Indonesia
Cengkareng General Hospital
Jakarta, DKI Jakarta, Indonesia
Sponsors and Collaborators
Faculty of Medicine, Tarumanagara University
Cengkareng General Hospital
Investigators
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Study Chair: Andria Priyana, MD, FIHA Department of Cardiology, Faculty of Medicine, Tarumanagara University
Principal Investigator: Angela F Sunjaya Faculty of Medicine, Tarumanagara University
Principal Investigator: Anthony P Sunjaya Faculty of Medicine, Tarumanagara University

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Responsible Party: Angela Felicia Sunjaya, Co Principal Investigator, Faculty of Medicine, Tarumanagara University
ClinicalTrials.gov Identifier: NCT03596931     History of Changes
Other Study ID Numbers: APS004
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Felicia Sunjaya, Faculty of Medicine, Tarumanagara University:
acute coronary syndrome
statin
acute pulmonary edema
malignant arrhythmia
heart failure

Additional relevant MeSH terms:
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Syndrome
Heart Failure
Edema
Acute Coronary Syndrome
Pulmonary Edema
Arrhythmias, Cardiac
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Myocardial Ischemia
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents