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Primary Prevention With Statin and Incidence of Recurrent MI and Cardiogenic Shock in Post-ACS Patients

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ClinicalTrials.gov Identifier: NCT03596944
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 recurrent myocardial infarction, cardiogenic shock and mortality in ACS patients.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Recurrent Myocardial Infarction Cardiogenic Shock Drug: Statin

Detailed Description:

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 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 recurrent myocardial infarction, cardiogenic shock, mortality or combinations of them as diagnosed in the medical records. GRACE and TIMI Scores are calculated to predict in hospital and future mortality rates.


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Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Primary Prevention With Statin and Incidence of Recurrent Myocardial Infarction and Cardiogenic Shock in 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 for primary prevention
Drug: Statin
Prescribed with statins for primary prevention

Non-Statin
No documented history of statin use prior to Acute Coronary Syndrome



Primary Outcome Measures :
  1. Recurrent Myocardial Infarction [ Time Frame: Through study completion, an average of 1 year ]
    Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

  2. Cardiogenic Shock [ Time Frame: Through study completion, an average of 1 year ]
    Clinical Diagnosis of Cardiogenic Shock reported in medical records

  3. Mortality [ Time Frame: Through study completion, an average of 1 year ]
    Patient death reported in medical records


Other Outcome Measures:
  1. GRACE Score [ Time Frame: Through study completion, an average of 1 year ]
    GRACE (Global Registry of Acute Coronary Events) mortality risk score

  2. TIMI Score [ Time Frame: Through study completion, an average of 1 year ]
    Thrombolysis In Myocardial Infarction (TIMI) mortality risk score



Information from the National Library of Medicine

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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 International Classification of Diseases (ICD)10 coding of I24.9
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unavailability of electrocardiographic findings, cardiac marker results, GRACE and TIMI score parameters
  • 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): NCT03596944


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: Angela F Sunjaya Faculty of Medicine, Tarumanagara University
Principal Investigator: Anthony P Sunjaya Faculty of Medicine, Tarumanagara University
Principal Investigator: Andria Priyana, MD, FIHA Department of Cardiology, Faculty of Medicine, Tarumanagara University

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Responsible Party: Angela Felicia Sunjaya, Principal Investigator, Faculty of Medicine, Tarumanagara University
ClinicalTrials.gov Identifier: NCT03596944     History of Changes
Other Study ID Numbers: APS005
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
mortality
GRACE score
TIMI score

Additional relevant MeSH terms:
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Syndrome
Infarction
Myocardial Infarction
Shock
Acute Coronary Syndrome
Shock, Cardiogenic
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents