Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia
NCT ID: NCT01271309
Last Updated: 2013-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
170 participants
OBSERVATIONAL
2007-07-31
2013-07-31
Brief Summary
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Detailed Description
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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.
EXPECTED RESULTS:
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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Thoracic pain lasting at least 20 min and ST changes or left B block, not present in previous ECG.
* MI confirmed by elevation of troponin I and CK-MB.
* Patients with Killip II e III LV dysfunction will be included.
Exclusion Criteria
* HF symptoms resistant to therapy
* Haemoglobin\< 10 gr/dl
* Haemodynamic instability (systolic pressure \<90 mmHg after treatment)
* Alterations in haematopoiesys
* Concurrent neoplastic disease
* No written informed consent or other conditions that affect patient's compliance to protocol.
18 Years
ALL
No
Sponsors
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University Hospital of Ferrara
OTHER
IRCCS Multimedica
OTHER
Responsible Party
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Principal Investigators
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Marco Valgimigli, MD
Role: PRINCIPAL_INVESTIGATOR
University Ferrara Hospital
Locations
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Cardiology Dept. Arcispedale S.Anna
Ferrara, , Italy
IRCCS Multimedica
Milan, , Italy
Countries
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References
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Fortunato O, Spinetti G, Specchia C, Cangiano E, Valgimigli M, Madeddu P. Migratory activity of circulating progenitor cells and serum SDF-1alpha predict adverse events in patients with myocardial infarction. Cardiovasc Res. 2013 Nov 1;100(2):192-200. doi: 10.1093/cvr/cvt153. Epub 2013 Jun 12.
Other Identifiers
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05/2007_Ferrara
Identifier Type: -
Identifier Source: org_study_id