Acute Coronary SyndromeNCT03596931
Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
An observational study of Acute Coronary Syndrome and Acute Pulmonary Edema, run by Tarumanagara University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Acute Pulmonary Edema, Arrhythmias, Cardiac
- What is being tested?
- Statins (Cardiovascular Agents)
- How many people
- 130 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 without a prior history of heart failure, acute lung edema and arrhythmia.
Who may be able to join
- Clinical diagnosis of Acute Coronary Syndrome
- Presence of detail on statin prescription history
Who cannot join
- History of heart failure, acute lung edema and arrhythmia
- 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: Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
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.
Read the 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).
- Being tested
- Statins (Cardiovascular Agents)
- Keywords
- acute coronary syndrome, statin, acute pulmonary edema, malignant arrhythmia, heart failure
- Medical subject headings
- Acute Coronary Syndrome, Arrhythmias, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statins (Cardiovascular Agents)Drug
Prescribed with statins
| Study group | Role | What they receive |
|---|---|---|
| Statin | History of statin use prior to Acute Coronary Syndrome Receives: Drug: Statins (Cardiovascular Agents) | |
| Non-Statin | No documented history of statin use prior to Acute Coronary Syndrome |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Collaborators
- Cengkareng General Hospital
- Responsible party
- Principal investigator, Angela Felicia Sunjaya, Tarumanagara University
- Investigators
- Andria Priyana, MD, FIHA, Study chair, Department of Cardiology, Faculty of Medicine, Tarumanagara UniversityAngela F Sunjaya, Principal investigator, Tarumanagara UniversityAnthony P Sunjaya, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596931
- Sponsor's protocol ID
- APS004
- Status last verified
- Sep 2018
- First submitted
- 12 Jul 2018
- Last updated
- 12 Sep 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 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT03596931
- Acronym / sponsor ID
- APS004
- Keywords
- acute coronary syndrome, statin, acute pulmonary edema, malignant arrhythmia, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 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
- 24 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 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 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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | – | Drug: Statins (Cardiovascular Agents)History of statin use prior to Acute Coronary Syndrome |
| Non-Statin | – | –No documented history of statin use 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 without a prior history of heart failure, acute lung edema and arrhythmia.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Acute Coronary Syndrome
- Presence of detail on statin prescription history
Key exclusion criteria (3 listed)
- History of heart failure, acute lung edema and arrhythmia
- 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 |
|---|---|---|
| Statins (Cardiovascular Agents)Prescribed with statins | Drug | Statin |
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%.
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 12 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Andria Priyana, MD, FIHA study chair
Department of Cardiology, Faculty of Medicine, Tarumanagara University
Angela F Sunjaya principal investigator
Tarumanagara University
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 Acute Pulmonary Edema, 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 3 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 12 Sep 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 3 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 12 Sep 2018.