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Acute Coronary Syndrome in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03607201
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Cengkareng General Hospital
Information provided by (Responsible Party):
Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University

Brief Summary:
This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Diabetes Mellitus Heart Failure Acute Pulmonary Edema Cardiac Arrythmias Other: No intervention

Detailed Description:

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under International Classification of Disease (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 - diabetic and non-diabetic based on history of diabetes 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 : 86 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Comparing Clinical Profile and Outcomes of Acute Coronary Syndrome in Diabetic and Non-Diabetic Patients
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 31, 2018

Group/Cohort Intervention/treatment
Diabetic
History of diabetes prior to Acute Coronary Syndrome
Other: No intervention
Routine care

Non-diabetic
No documented history of diabetes prior to Acute Coronary Syndrome
Other: No intervention
Routine care




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%.

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

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

  6. 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 ICD-10 coding of I24.9.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on diabetes history

Exclusion Criteria:

  • 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): NCT03607201


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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Principal Investigator: Anthony P Sunjaya Faculty of Medicine, Tarumanagara University

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Responsible Party: Anthony Paulo Sunjaya, Principal Investigator, Faculty of Medicine, Tarumanagara University
ClinicalTrials.gov Identifier: NCT03607201     History of Changes
Other Study ID Numbers: APS006
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 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 Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University:
acute coronary syndrome
diabetes
heart failure
acute pulmonary edema
malignant arrhythmia

Additional relevant MeSH terms:
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Syndrome
Diabetes Mellitus
Heart Failure
Acute Coronary Syndrome
Arrhythmias, Cardiac
Pulmonary Edema
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases