Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia

Myocardial Infarction Clinical Trial

Official title:

Migratory and Angiogenic Dysfunction of Circulating CD133 Stem Cells: a New Prognostic Marker in Myocardial Ischemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271309
• Other study ID #: 05/2007_Ferrara
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: August 7, 2013
• Start date: July 2007
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: IRCCS Multimedica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The present project aims to determine whether a deficit in migration of stem cells could be implicated in the failure to mount an adequate collateralization after Myocardial Infarction (MI) and thereby facilitate the development of post-ischemic heart failure (HF) and to dissect underlying molecular mechanisms. Furthermore, the investigators wish to determine the predictive value of stem cell migration assay in patients with MI.

Description:

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2013
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years

• 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:

• Patients reporting thoracic pain 24 hours prior to hospitalization

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	Cardiology Dept. Arcispedale S.Anna	Ferrara
Italy	IRCCS Multimedica	Milan

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Multimedica	University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Fortunato O, Spinetti G, Specchia C, Cangiano E, Valgimigli M, Madeddu P. Migratory activity of circulating progenitor cells and serum SDF-1a predict adverse events in patients with myocardial infarction. Cardiovasc Res. 2013 Nov 1;100(2):192-200. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic value of CD133+ stem cells in MI	Correlation of clinical parameters of disease evolution and biological features	12 months	No
Secondary	Correlation of disease evolution and other biomarkers		12 months	No