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Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Ferrara
Information provided by (Responsible Party):
IRCCS Multimedica
ClinicalTrials.gov Identifier:
NCT01271309
First received: January 5, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by IRCCS Multimedica:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Correlation of disease evolution and other biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: July 2007
Study Completion Date: July 2013
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients will be recruited sequentially at the Operative Unit of Ferrara having the following characteristics: Thoracic pain lasting at least 20 min and ST changes or left B block, not present in previous ECG. MI will be confirmed by elevation of troponin I and CK-MB. Patients will be treated according to international guidelines. With regard to medical treatment, this will include all available drugs except for statins, which will be inserted only 14 days post-MI, to avoid the confounding effect of these drugs on stem cell biology.

Patients reporting thoracic pain 24 hours prior to hospitalization will be excluded. Similarly, those with HF symptoms resistant to therapy will be excluded. By contrast, patients with Killip II e III LV dysfunction will be included.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271309

Locations
Italy
Cardiology Dept. Arcispedale S.Anna
Ferrara, Italy
IRCCS Multimedica
Milan, Italy
Sponsors and Collaborators
IRCCS Multimedica
University Hospital of Ferrara
Investigators
Principal Investigator: Marco Valgimigli, MD University Ferrara Hospital
  More Information

Publications:
Responsible Party: IRCCS Multimedica
ClinicalTrials.gov Identifier: NCT01271309     History of Changes
Other Study ID Numbers: 05/2007_Ferrara
Study First Received: January 5, 2011
Last Updated: August 7, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014