Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia
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|ClinicalTrials.gov Identifier: NCT01271309|
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : August 9, 2013
|Condition or disease|
MAIN OBJECTIVES OF THE STUDY:
Characterization of circulating CD133+ stem cells in a group of 170 patients with MI (mean post-MI follow up, 6 months):
- Counting total mononuclear cells and FACS analysis of CD133 stem cells.
- Characterization of CD133+ stem cell biology: Migratory assay, imaging of cytoskeleton, angiogenesis tests in vitro.
- Evaluation of migratory signalling, with specific focus on the PI3K/Akt/eNOS system.
Assessment of the prognostic value of the stem cell migration assay.
- Relationship between cell biology tests on CD133+ cells and changes in circulating cytokines and pro-angiogenic factors after MI.
- Assessment of area at risk by ECG-synchronized Single Photon Emission Computed Tomography (gated-SPECT) in subgroups with different patterns of stem cell migratory tests.
- Assessment of ventricular remodelling (echocardiography, NMR) in relation with patterns of stem cell migratory test.
Clarification of the implication of stem cell migratory deficit in post-ischemic HF.
- Identification of underlying mechanisms
- Identification of a cellular marker for prediction of patients at risk of HF.
RELEVANCE TO PUBLIC HEALTH:
- Introduction of a biological test for the early diagnosis of post-MI HF
- Recognition of therapeutic targets for the rescue of stem cell migratory liabilities
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Migratory and Angiogenic Dysfunction of Circulating CD133 Stem Cells: a New Prognostic Marker in Myocardial Ischemia.|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||July 2013|
Acute Myocardial Infarction patients
Patients with thoracic pain lasting at least 20 min and ST changes or left B block, not present in previous ECG.
- Prognostic value of CD133+ stem cells in MI [ Time Frame: 12 months ]Correlation of clinical parameters of disease evolution and biological features
- Correlation of disease evolution and other biomarkers [ Time Frame: 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01271309
|Cardiology Dept. Arcispedale S.Anna|
|Principal Investigator:||Marco Valgimigli, MD||University Ferrara Hospital|