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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191879
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Other: Blood test

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 Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison of p53-induced Genes Activation as Possible Markers Differentiating Between Patients Presenting With Acute Myocardial Infarction and Controls
Study Start Date : November 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
acute MI group
Patients presenting with acute ST elevation myocardial infarction, admitted to the intensive cardiac care unit and that are planned for emergency primary PCI
Other: Blood test
Blood test

Patients undergoing a non-invasive evaluation of possible myocardial ischemia.
Other: Blood test
Blood test

Primary Outcome Measures :
  1. Expression of P53 induced genes in patients with and without acute myocardial infarction [ Time Frame: Up to 4 hours following recruitment ]

Secondary Outcome Measures :
  1. Correlation between P53 associated gene expression with troponin level [ Time Frame: After 5 days from recruitment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Aacute MI group- Patients with acute ST elevation MI planned for emergency primary PCI

Controls: Patients undergoing non-invasive evaluation of possible myocardial ischemia


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191879

Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Meir Medical Center Identifier: NCT01191879     History of Changes
Other Study ID Numbers: MRNA-MI-1
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases