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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01191879
First received: August 8, 2010
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention
Acute Myocardial Infarction
Other: Blood test

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Expression of P53 induced genes in patients with and without acute myocardial infarction [ Time Frame: Up to 4 hours following recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between P53 associated gene expression with troponin level [ Time Frame: After 5 days from recruitment ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Controls
Patients undergoing a non-invasive evaluation of possible myocardial ischemia.
Other: Blood test
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191879

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01191879     History of Changes
Other Study ID Numbers: MRNA-MI-1
Study First Received: August 8, 2010
Last Updated: October 30, 2012
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on October 23, 2014