NCT01191879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

11 months

First QC Date

August 8, 2010

Last Update Submit

October 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Expression of P53 induced genes in patients with and without acute myocardial infarction

    Up to 4 hours following recruitment

Secondary Outcomes (1)

  • Correlation between P53 associated gene expression with troponin level

    After 5 days from recruitment

Study Arms (2)

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

Controls

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

Other: Blood test

Interventions

Blood test

Controlsacute MI group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, Israel

Location

Related 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. doi: 10.1073/pnas.0404998101. Epub 2004 Aug 9.

    PMID: 15302922BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2010

First Posted

August 31, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations