Myocardial InfarctionNCT01870258
Myocardial Infarction Prediction
A study testing ANN prediction of myocardial infarction in people with Myocardial Infarction and Artificial Neural Network, run by Shiraz University of Medical Sciences.
Trial summary
prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Myocardial Infarction, Artificial Neural Network
- What is being tested?
- ANN prediction of myocardial infarction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2012
- Phase
- Interventional
- 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 40 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with chest pain refered to ER with nondiagnostic ECG
Who cannot join
- 1) Absence of a history of myocardial infarction
- 2) Absence of bundle branch block, Wolf-Parkinson-White abnormality, ventricular hypertrophy or previous ECG signs of myocardial infarction,
- 3) Absence of a history of percutaneous coronary surgery or coronary artery bypass grafting,
- 4) Absence of ECG abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.
About this study
Official title: Prediction of Acute Myocardial Infarction With Artificial Neural Networks in Patients With Nondiagnostic Electrocardiogram
prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks
Read the detailed description
Myocardial infarction remains one the leading causes of mortality and morbidity and involves a high cost of care. Early prediction can be helpful in preventing the development of myocardial infarction with appropriate diagnosis and treatment. Artificial neural networks have opened new horizons in learning about the natural history of diseases and predicting cardiac disease.
Methods: A total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram (ECG) were enrolled and followed for 2 weeks in two groups based on the appearance of myocardial infarction. Two types of data were used for all patients: nominal (clinical data) and quantitative (ECG findings). Two different artificial neural networks - radial basis function (RBF) and multi-layer perceptron (MLP) - were used.
- Conditions
- Myocardial Infarction, Artificial Neural Network
- Being tested
- ANN prediction of myocardial infarction
- Keywords
- Myocardial infarction, artificial neural networks, Electrocardiography
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANN prediction of myocardial infarctionOther
Also called sofware detected risk of new myocardial infraction
| Study group | Role | What they receive |
|---|---|---|
| those without MI in 2 weeks | Placebo comparator | patient without MI in 2 weeks Receives: Other: ANN prediction of myocardial infarction |
| patient with MI | Active comparator | group with MI in 2 weeks Receives: Other: ANN prediction of myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial infarction
Measured: 2 weeks
Secondary outcomes (1)
hospital admission due to cardiac events
may be includes unstable angina, cardiac arrest or PCIor CABG
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870258
- Sponsor's protocol ID
- 90-8037
- Status last verified
- Jun 2013
- First submitted
- 24 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Myocardial Infarction With Artificial Neural Networks in Patients With Nondiagnostic Electrocardiogram
- ClinicalTrials.gov ID
- NCT01870258
- Acronym / sponsor ID
- 90-8037
- Conditions
- Myocardial Infarction, Artificial Neural Network
- Keywords
- Myocardial infarction, artificial neural networks, Electrocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jun 2013 (estimated)
- 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.
prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks
Detailed description
Myocardial infarction remains one the leading causes of mortality and morbidity and involves a high cost of care. Early prediction can be helpful in preventing the development of myocardial infarction with appropriate diagnosis and treatment. Artificial neural networks have opened new horizons in learning about the natural history of diseases and predicting cardiac disease.
Methods: A total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram (ECG) were enrolled and followed for 2 weeks in two groups based on the appearance of myocardial infarction. Two types of data were used for all patients: nominal (clinical data) and quantitative (ECG findings). Two different artificial neural networks - radial basis function (RBF) and multi-layer perceptron (MLP) - were used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| those without MI in 2 weeks | Placebo comparator | Other: ANN prediction of myocardial infarctionpatient without MI in 2 weeks |
| patient with MI | Active comparator | Other: ANN prediction of myocardial infarctiongroup with MI in 2 weeks |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with chest pain refered to ER with nondiagnostic ECG
Key exclusion criteria (4 listed)
- 1) Absence of a history of myocardial infarction
- 2) Absence of bundle branch block, Wolf-Parkinson-White abnormality, ventricular hypertrophy or previous ECG signs of myocardial infarction,
- 3) Absence of a history of percutaneous coronary surgery or coronary artery bypass grafting,
- 4) Absence of ECG abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.
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 |
|---|---|---|
| ANN prediction of myocardial infarctionAlso: sofware detected risk of new myocardial infraction | Other | patient with MI, those without MI in 2 weeks |
Primary outcome
myocardial infarction
Time frame: 2 weeks
1 secondary outcome
hospital admission due to cardiac events
Time frame: 2 weeks
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 6 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ANN prediction of myocardial infarction in people with Myocardial Infarction and Artificial Neural Network, run by Shiraz University of Medical Sciences.
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: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
myocardial infarction (time frame: 2 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 6 Jun 2013.