Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03596931
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2018-07-12
Brief Title:
Prior Statin Use and Risk of CHF ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
Sponsor:
Tarumanagara University
Organization:
Tarumanagara University
Study Overview
Official Title:
Prior Statin Use and Risk of Heart Failure Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Adult patients 18 years of age with acute coronary syndrome which are diagnosed under ICD-10 coding of I249 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 I249 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 13 of the lungs with oxygen saturation 90 Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia VT or ventricular fibrillation VF
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 13 of the lungs with oxygen saturation 90 Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia VT or ventricular fibrillation VF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None