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Completed

NCT Number: NCT01271309

Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Dept. Arcispedale S.Anna, Ferrara, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prognostic value of CD133+ stem cells in MI

    Time frame: 12 months

    Correlation of clinical parameters of disease evolution and biological features

Secondary outcomes

  1. Correlation of disease evolution and other biomarkers

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

IRCCS Multimedica

Other

Collaborators

  • University Hospital of Ferrara

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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