Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia

NCT01271309 | Completed

• 1 other identifier: 05/2007_Ferrara
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Prognostic value of CD133+ stem cells in MI

  Correlation of clinical parameters of disease evolution and biological features

  12 months

Secondary Outcomes (1)

• Correlation of disease evolution and other biomarkers

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Multimedica: lead
• University Hospital of Ferrara: collaborator

Study Sites (2)

Cardiology Dept. Arcispedale S.Anna

Ferrara, Italy

Location

IRCCS Multimedica

Milan, Italy

Location

Related Publications (1)

• 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.

  PMID: 23761401 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Marco Valgimigli, MD

  University Ferrara Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

IT (2)