Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Migratory and Angiogenic Dysfunction of Circulating CD133 Stem Cells: a New Prognostic Marker in Myocardial Ischemia.|
- Prognostic value of CD133+ stem cells in MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]Correlation of clinical parameters of disease evolution and biological features
- Correlation of disease evolution and other biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||July 2013|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271309
|Cardiology Dept. Arcispedale S.Anna|
|Principal Investigator:||Marco Valgimigli, MD||University Ferrara Hospital|