Acute Coronary SyndromeNCT03286491
Clinical Decision Support System to Define 30 Day Adverse Clinical Events for Emergency Department Acute Coronary Syndromes
An observational study of Acute Coronary Syndrome and Clinical Decision Support System, run by Turkish Ministry of Health Izmir Teaching Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Clinical Decision Support System
- What is being tested?
- Further cardiac imaging
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2017to 1 Feb 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting to emergency deparmtent with acute chest pain consistent with acute coronary syndrome will be included for analysis.
Who may be able to join
- Presenting to emergency department with acute chest pain consistent with acute coronary syndrome
Who cannot join
- Patients with less than 18 years old
- Patients presenting with ST-segment elevation myocardial infarction
- Patients presenting with other causes of acute chest pain (pneumothorax, pulmonary -embolism, aortic dissection
- Decline to participate in study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Bozyaka Training and Research Hospital
Izmir, 35000
Nesli Belen, M.D., 90-551-4363001, neslibelen@yahoo.com
Serhat Akay, M.D., 90-505-7079350, howls_Castle@mynet.com
About this study
Official title: Development of Clinical Decision Support System to Define 30 Day Adverse Clinical Events (Non Fatal Myocardial Infarction, Cardiac Related Death or Coronary Intervention) for Patients Presenting to Emergency Department With Acute Coronary Syndrome
Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.
Read the detailed description
Acute coronary syndromes are among main complains for patients presenting to emergency department and create a burden to emergency departments and hospitals. Risk classification systems were developed and used to classify patients to appropriate risk groups. According to risk classification, different diagnosis and treatment modalities can be used and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.
- Being tested
- Further cardiac imaging
- Keywords
- acute coronary syndrome, risk classification, 30 day adverse event, clinical decision support system
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Further cardiac imagingDiagnostic test
Study patients will be reviewed whether they will have coronary interventions in 30 days
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with acute coronary syndrome | Patients presenting to emergency department with acute coronary syndrome Receives: Diagnostic Test: Further cardiac imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non fatal myocardial infarction, cardiac related death or coronary intervention in 30 days
Patients will be screened for 30 days for Non fatal myocardial infarction, cardiac related death or coronary intervention (coronary angiogram, coronary artery bypass surgery)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start12 Aug 2017
- Primary completion12 Dec 2017 (estimated)
- Study completion1 Feb 2018 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Ministry of Health Izmir Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serhat Akay, Turkish Ministry of Health Izmir Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286491
- Sponsor's protocol ID
- TurkishMOHITH
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2017
- Last updated
- 18 Sep 2017
- 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 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Decision Support System to Define 30 Day Adverse Clinical Events (Non Fatal Myocardial Infarction, Cardiac Related Death or Coronary Intervention) for Patients Presenting to Emergency Department With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03286491
- Acronym / sponsor ID
- TurkishMOHITH
- Keywords
- acute coronary syndrome, risk classification, 30 day adverse event, clinical decision support system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Turkish Ministry of Health Izmir Teaching HospitalOther government
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 12 Dec 2017 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 18 Sep 2017 (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.
Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.
Detailed description
Acute coronary syndromes are among main complains for patients presenting to emergency department and create a burden to emergency departments and hospitals. Risk classification systems were developed and used to classify patients to appropriate risk groups. According to risk classification, different diagnosis and treatment modalities can be used and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with acute coronary syndrome | – | Diagnostic Test: Further cardiac imagingPatients presenting to emergency department with acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to emergency deparmtent with acute chest pain consistent with acute coronary syndrome will be included for analysis.
Key inclusion criteria (1 listed)
- Presenting to emergency department with acute chest pain consistent with acute coronary syndrome
Key exclusion criteria (4 listed)
- Patients with less than 18 years old
- Patients presenting with ST-segment elevation myocardial infarction
- Patients presenting with other causes of acute chest pain (pneumothorax, pulmonary -embolism, aortic dissection
- Decline to participate in study
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 |
|---|---|---|
| Further cardiac imagingStudy patients will be reviewed whether they will have coronary interventions in 30 days | Diagnostic test | Patients presenting with acute coronary syndrome |
Primary outcome
Non fatal myocardial infarction, cardiac related death or coronary intervention in 30 days
Time frame: 30 days
Patients will be screened for 30 days for Non fatal myocardial infarction, cardiac related death or coronary intervention (coronary angiogram, coronary artery bypass surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- 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 Acute Coronary Syndrome and Clinical Decision Support System, run by Turkish Ministry of Health Izmir Teaching Hospital at 1 site in Turkey (Türkiye).
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 4 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 18 Sep 2017. 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 Turkey (Türkiye). 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 Nesli Belen, M.D. (90-551-4363001, neslibelen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non fatal myocardial infarction, cardiac related death or coronary intervention in 30 days (time frame: 30 days). 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 18 Sep 2017.