Acute Coronary SyndromeNCT03607201
Acute Coronary Syndrome in Diabetic Patients
An observational study of Acute Coronary Syndrome and Diabetes Mellitus, run by Tarumanagara University at 1 site in Indonesia.
Trial summary
This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Diabetes Mellitus, Heart Failure
- How many people
- 86 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2017to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9.
Who may be able to join
- Clinical diagnosis of Acute Coronary Syndrome
- Presence of detail on diabetes history
Who cannot join
- Unavailability of electrocardiographic findings, cardiac marker results
- Incomplete records of prior medical and treatment history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Clinical Profile and Outcomes of Acute Coronary Syndrome in Diabetic and Non-Diabetic Patients
This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.
Read the 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).
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus, Heart Failure, Acute Pulmonary Edema, Cardiac Arrythmias
- Being tested
- No intervention
- Keywords
- acute coronary syndrome, diabetes, heart failure, acute pulmonary edema, malignant arrhythmia
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | History of diabetes prior to Acute Coronary Syndrome Receives: Other: No intervention | |
| Non-diabetic | No documented history of diabetes prior to Acute Coronary Syndrome Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure
Based on echocardiographic findings from the medical records
Measured: Through study completion, an average of 1 year
Malignant Arrhythmia
Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)
Measured: 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%.
Measured: Through study completion, an average of 1 year
Cardiogenic Shock
Clinical Diagnosis of Cardiogenic Shock reported in medical records
Measured: Through study completion, an average of 1 year
Recurrent Myocardial Infarction
Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records
Measured: Through study completion, an average of 1 year
Mortality
Patient death reported in medical records
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Aug 2017
- Primary completion30 Jun 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Collaborators
- Cengkareng General Hospital
- Responsible party
- Principal investigator, Anthony Paulo Sunjaya, Tarumanagara University
- Investigators
- Anthony P Sunjaya, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607201
- Sponsor's protocol ID
- APS006
- Status last verified
- Oct 2018
- First submitted
- 23 Jul 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Clinical Profile and Outcomes of Acute Coronary Syndrome in Diabetic and Non-Diabetic Patients
- ClinicalTrials.gov ID
- NCT03607201
- Acronym / sponsor ID
- APS006
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus, Heart Failure, Acute Pulmonary Edema, Cardiac Arrythmias
- Keywords
- acute coronary syndrome, diabetes, heart failure, acute pulmonary edema, malignant arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Collaborators
- Cengkareng General Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the clinical profile and outcomes of acute coronary syndrome patients with diabetes and without diabetes.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | Other: No interventionHistory of diabetes prior to Acute Coronary Syndrome |
| Non-diabetic | – | Other: No interventionNo documented history of diabetes prior to Acute Coronary Syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Acute Coronary Syndrome
- Presence of detail on diabetes history
Key exclusion criteria (2 listed)
- Unavailability of electrocardiographic findings, cardiac marker results
- Incomplete records of prior medical and treatment history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionRoutine care | Other | Diabetic, Non-diabetic |
Primary outcome
Heart Failure
Time frame: Through study completion, an average of 1 year
Based on echocardiographic findings from the medical records
Malignant Arrhythmia
Time frame: Through study completion, an average of 1 year
Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)
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%.
Cardiogenic Shock
Time frame: Through study completion, an average of 1 year
Clinical Diagnosis of Cardiogenic Shock reported in medical records
Recurrent Myocardial Infarction
Time frame: Through study completion, an average of 1 year
Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records
Mortality
Time frame: Through study completion, an average of 1 year
Patient death reported in medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Coronary Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Sunjaya principal investigator
Tarumanagara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Diabetes Mellitus, run by Tarumanagara University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.