Myocardial InfarctionNCT01271309
Stem Cell Migratory Activity: Prognostic Marker in Myocardial Ischemia
An observational study of Myocardial Infarction, run by IRCCS Multimedica at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 170 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2007to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Migratory and Angiogenic Dysfunction of Circulating CD133 Stem Cells: a New 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.
Read the 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
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of CD133+ stem cells in MI
Correlation of clinical parameters of disease evolution and biological features
Measured: 12 months
Secondary outcomes (1)
Correlation of disease evolution and other biomarkers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Ferrara
- Responsible party
- Sponsor
- Investigators
- Marco Valgimigli, MD, Principal investigator, University Ferrara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271309
- Sponsor's protocol ID
- 05/2007_Ferrara
- Status last verified
- Aug 2013
- First submitted
- 5 Jan 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23761401
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migratory and Angiogenic Dysfunction of Circulating CD133 Stem Cells: a New Prognostic Marker in Myocardial Ischemia.
- ClinicalTrials.gov ID
- NCT01271309
- Acronym / sponsor ID
- 05/2007_Ferrara
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Collaborators
- University Hospital of Ferrara
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of CD133+ stem cells in MI
Time frame: 12 months
Correlation of clinical parameters of disease evolution and biological features
1 secondary outcome
Correlation of disease evolution and other biomarkers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Results publication: PubMed 23761401Fortunato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Valgimigli, MD principal investigator
University Ferrara Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by IRCCS Multimedica at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of CD133+ stem cells in MI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.