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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01870258
Other study ID # 90-8037
Secondary ID
Status Completed
Phase N/A
First received May 24, 2013
Last updated June 4, 2013
Start date January 2011
Est. completion date June 2012

Study information

Verified date June 2013
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: national institiute of health
Study type Interventional

Clinical Trial Summary

prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks


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.


Recruitment information / eligibility

Status Completed
Enrollment 1100
Est. completion date June 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 72 Years
Eligibility Inclusion Criteria:

- patient with chest pain refered to ER with nondiagnostic ECG

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

Other:
ANN prediction of myocardial infarction


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary myocardial infarction 2 weeks Yes
Secondary hospital admission due to cardiac events may be includes unstable angina, cardiac arrest or PCIor CABG 2 weeks Yes
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