## Protocol Section
### Identification Module
**NCT ID:** NCT01191879

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

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

#### Organization Study ID Info
**ID:** MRNA-MI-1
#### Organization
**Class:** OTHER
**Full Name:** Meir Medical Center
### Status Module
#### Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-10-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-10-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Start Date
**Date:** 2010-11

**Status Verified Date:** 2012-10

#### Study First Post Date
**Date:** 2010-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 2010-08-08
**Study First Submit QC Date:** 2010-08-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Meir Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Myocardial Infarction

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 79

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients presenting with acute ST elevation myocardial infarction, admitted to the intensive cardiac care unit and that are planned for emergency primary PCI

**Intervention Names:**

- Other: Blood test

**Label:** acute MI group

#### Arm Group 2

**Description:** Patients undergoing a non-invasive evaluation of possible myocardial ischemia.

**Intervention Names:**

- Other: Blood test

**Label:** Controls

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Controls

- acute MI group

**Description:** Blood test

**Name:** Blood test

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Expression of P53 induced genes in patients with and without acute myocardial infarction

**Time Frame:** Up to 4 hours following recruitment

#### Secondary Outcomes

**Measure:** Correlation between P53 associated gene expression with troponin level

**Time Frame:** After 5 days from recruitment

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kfar Saba

**Country:** Israel

**Facility:** Meir Medical Center

### References Module

#### References

**Citation:** 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. doi: 10.1073/pnas.0404998101. Epub 2004 Aug 9.

**PMID:** 15302922

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000007238

- Term: Infarction

### Misc Info Module

- Version Holder: 2024-05-24
