ST-segment Elevation Myocardial Infarction (STEMI)ANGIO-STEMINCT06586424
The Prognostic Value of Anion Gap in Predicting Major Adverse Cardiovascular Events Among Patients With ST-Segment Elevation Myocardial Infarction
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
This study aims to evaluate the prognostic value of the anion gap in predicting major adverse cardiovascular events among patients with ST-segment elevation myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Anion gap
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 5 Oct 2024
- How long will I take part?
- 7 Days
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with ST-segment elevation myocardial infarction who underwent PPCI
Who may be able to join
- Adults with 18 - 70 years old with diagnosis of STEMI who underwent PPCI
Who cannot join
- History of heart failure due to any causes
- Cardiogenic shock before PPCI
- Any infection at the time of presentation
- Pregnant woman
- Other causes of high anion gap levels such as chronic kidney disease, metabolic acidosis, etc
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi Central General Hospital
Semarang, Central of Java
Leo Deddy Pradipta, +6281316499074, dancingdeagle@gmail.com
About this study
This study aims to evaluate the prognostic value of the anion gap in predicting major adverse cardiovascular events among patients with ST-segment elevation myocardial infarction. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as ST-segment elevation myocardial infarction and underwent primary percutaneous coronary intervention. The data consist of demographic data, clinical presentation, laboratory, and angiography result were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
- Being tested
- Anion gap
- Keywords
- anion gap, major adverse cardiovascular events, st-segment elevation myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anion gapDiagnostic test
Patient was taken blood examination before PPCI
| Study group | Role | What they receive |
|---|---|---|
| MACE group | Patient with STEMI who suffered major adverse cardiovascular events (MACE) after underwent primary percutaneous coronary intervention (PPCI) Receives: Diagnostic Test: Anion gap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Measured: During hospitalization, up to 1 weeks
Secondary outcomes (6)
Incidence of mortality
Measured: During hospitalization, up to 1 weeks
Incidence of reinfarction
Measured: During hospitalization, up to 1 weeks
Incidence of stroke
Measured: During hospitalization, up to 1 weeks
Incidence of lethal arrhythmia
Measured: During hospitalization, up to 1 weeks
Incidence of acute lung oedema
Measured: During hospitalization, up to 1 weeks
Incidence of cardiogenic shock
Measured: During hospitalization, up to 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiqur Rifqi, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586424
- Sponsor's protocol ID
- Undip_Kardio 2
- Acronym
- ANGIO-STEMI
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Anion Gap in Predicting Major Adverse Cardiovascular Events Among Patients With ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06586424
- Acronym / sponsor ID
- ANGIO-STEMI / Undip_Kardio 2
- Keywords
- anion gap, major adverse cardiovascular events, st-segment elevation myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (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 prognostic value of the anion gap in predicting major adverse cardiovascular events among patients with ST-segment elevation myocardial infarction. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as ST-segment elevation myocardial infarction and underwent primary percutaneous coronary intervention. The data consist of demographic data, clinical presentation, laboratory, and angiography result were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MACE group | – | Diagnostic Test: Anion gapPatient with STEMI who suffered major adverse cardiovascular events (MACE) after underwent primary percutaneous coronary intervention (PPCI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ST-segment elevation myocardial infarction who underwent PPCI
Key inclusion criteria (1 listed)
- Adults with 18 - 70 years old with diagnosis of STEMI who underwent PPCI
Key exclusion criteria (5 listed)
- History of heart failure due to any causes
- Cardiogenic shock before PPCI
- Any infection at the time of presentation
- Pregnant woman
- Other causes of high anion gap levels such as chronic kidney disease, metabolic acidosis, etc
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 |
|---|---|---|
| Anion gapPatient was taken blood examination before PPCI | Diagnostic test | MACE group |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: During hospitalization, up to 1 weeks
6 secondary outcomes
Incidence of mortality
Time frame: During hospitalization, up to 1 weeks
Incidence of reinfarction
Time frame: During hospitalization, up to 1 weeks
Incidence of stroke
Time frame: During hospitalization, up to 1 weeks
Incidence of lethal arrhythmia
Time frame: During hospitalization, up to 1 weeks
Incidence of acute lung oedema
Time frame: During hospitalization, up to 1 weeks
Incidence of cardiogenic shock
Time frame: During hospitalization, up to 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
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 ST-segment Elevation Myocardial Infarction (STEMI), run by Universitas Diponegoro 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Deddy Pradipta (+6281316499074, dancingdeagle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: During hospitalization, up to 1 weeks). 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 19 Sep 2024.