A Comparison of p53-induced Genes Activation in Patients With and Without Acute Myocardial Infarction

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Other: Blood test

• Registration Number: NCT01191879
• Lead Sponsor: Meir Medical Center

Brief Summary

The purpose of this study is to compare p53-induced genes activation as possible markers differentiating between patients presenting with acute myocardial infarction and controls.

Detailed Description

The diagnosis of acute myocardial infarction is based on the rise of bio-markers for cardiac necrosis such as troponin. While troponin measurement is highly sensitive for myocardial necrosis it has several limitations that influence its clinical use. First, since the troponin test is reliable only after 4-6 hours from symptoms onset, it has only limited value in the assessment of patients presenting earlier. Second, several clinical situations, most commonly renal dysfunction, are associated with increased troponin level and therefore may decrease the specificity of the test. Third, since troponin rise indicates myocardial infarction it is not useful in the common situations where there is myocardial ischemia without necrosis.

The P53 is a tumor suppressing gene activated in different stressful situations including hypoxia. This activation is associated with accelerated transcription (up to 30-50 folds from baseline) of different genes that are involved in apoptosis, DNA repair and in stopping the cell cycle. A study on pregnant women demonstrated high levels of fetal mRNA of these genes in maternal circulation. This gene expression correlated with other signs of fetal stress associated with hypoxia. Myocardial ischemia is another stressful event associated with tissue hypoxia. Nevertheless, the association of this gene expression with myocardial ischemia has not been investigated yet.

Study Timeline

• Study First Submitted: 2010-08-08
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Study Start: 2010-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

Inclusion Criteria

Acute MI group:

Patient presenting with chest pain lasting for at leasY 1 hour and no more than 6 hours accompanied by 1 of the following ECG criteria:

• ST segment elevation of anterior or inferior wall (at least 2 consecutive leads)
• New LBBB

Controls:

• Patients undergoing non-invasive evaluation of possible myocardial ischemia

Exclusion Criteria

• Chronic lung disease requiring chronic treatment
• Any malignancy in the 5 year prior to enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute MI group	Blood test	Patients presenting with acute ST elevation myocardial infarction, admitted to the intensive cardiac care unit and that are planned for emergency primary PCI
Controls	Blood test	Patients undergoing a non-invasive evaluation of possible myocardial ischemia.

Primary Outcome Measures

Name	Time	Method
Expression of P53 induced genes in patients with and without acute myocardial infarction	Up to 4 hours following recruitment

Secondary Outcome Measures

Name	Time	Method
Correlation between P53 associated gene expression with troponin level	After 5 days from recruitment

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel