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

Acute Myocardial Infarction Clinical Trial

Official title:

A Comparison of p53-induced Genes Activation as Possible Markers Differentiating Between Patients Presenting With Acute Myocardial Infarction and Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191879
• Other study ID #: MRNA-MI-1
• Status: Completed
• Phase: N/A
• First received: August 8, 2010
• Last updated: October 30, 2012
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• Blood test
Blood test

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Ashur-Fabian O, Avivi A, Trakhtenbrot L, Adamsky K, Cohen M, Kajakaro G, Joel A, Amariglio N, Nevo E, Rechavi G. Evolution of p53 in hypoxia-stressed Spalax mimics human tumor mutation. Proc Natl Acad Sci U S A. 2004 Aug 17;101(33):12236-41. Epub 2004 Aug 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of P53 induced genes in patients with and without acute myocardial infarction		Up to 4 hours following recruitment	No
Secondary	Correlation between P53 associated gene expression with troponin level		After 5 days from recruitment	No