Myocardial InfarctionNCT01127113
Inflammatory Cell Trafficking After Myocardial Infarction
A study testing Infusion of investigational product and Cardiac magnetic resonance imaging in people with Myocardial Infarction and Inflammation, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty 'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a blood clot and blockage of the artery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Inflammation
- What is being tested?
- Infusion of investigational product and Cardiac magnetic resonance imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Mar 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation with acute ST segment elevation myocardial infarction:
- 1 mm ST elevation in at least two contiguous limb leads, or
- 2 mm ST elevation in at least two contiguous praecordial leads, or new onset bundle branch block
- Successful treatment with primary percutaneous coronary intervention Restoration of TIMI grade 3 flow in infarct-related artery
- Troponin I ≥10 IU/mL at 12 hours after the onset of chest pain
- Age 18 - 80 years
Who cannot join
- Left main stem or severe multi-vessel coronary artery disease
- Continued symptoms of angina at rest or minimal exertion
- Atrial fibrillation
- Symptomatic heart failure; Killip Class ≥2.
- Hepatic or renal failure (estimated glomerular filtration rate <25 mL/min)
- Terminal illness or malignancy
Show all 10Show fewer
- Anaemia
- Contraindication to magnetic resonance imaging
- Hepatitis B, hepatitis C, HTLV, HIV or syphilis infection
- Patients at risk of allergy to protamine (fish allergy, infertile men, previous vasectomy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SU
About this study
Official title: Inflammatory Cell Labelling and Tracking With Magnetic Resonance Imaging After Myocardial Infarction
Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty 'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a blood clot and blockage of the artery. The heart muscle normally supplied by the artery becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of the heart muscle damage is caused by overactivation of inflammatory cells. Whilst inflammation can be beneficial in healing processes, there is accumulating evidence that overactivation of inflammatory processes contributes to further muscle damage and cell death during myocardial infarction. We have recently developed a means of labelling human blood cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood to allow the cells to be tracked and seen in the body using a conventional magnetic resonance scanner.
In the proposed study we aim to recruit patients with recent heart attacks to perform similar cell labelling and reinjection of labelled cells into the same volunteer's blood stream via the arm to track the fate of the blood cells over the course of days to months. We think that the labelled inflammatory cells will 'home' to the site of the heart attack and will be visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the role of inflammatory cells in myocardial infarction, but also propose that, if successful, this technique could be used in the future to assess the effects of antiinflammatory treatments currently being developed for the treatment of patients with heart attacks. The technique could also be extended to allow labelling of other cell types, including stem cells, to let us further understand how these cells may contribute to repair of damaged organs including the heart.
- Conditions
- Myocardial Infarction, Inflammation
- Being tested
- Infusion of investigational product, Cardiac magnetic resonance imaging
- Keywords
- Myocardial infarction, Magnetic resonance imaging, Nanoparticles, Mononuclear cells, Cell tracking
- Medical subject headings
- Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of investigational productOther
Also called The investigational product will be either:, 1) Unlabelled autologous mononuclear cells, 2) Endorem (Guerbet, Paris) contrast alone, 3) Autologous mononuclear cells labelled with Endorem
The investigational product will be delivered via intravenous infusion
Cardiac magnetic resonance imagingOther
Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.
| Study group | Role | What they receive |
|---|---|---|
| SPIO-labelled mononuclear cells | Active comparator | Not described Receives: Other: Infusion of investigational product; Other: Cardiac magnetic resonance imaging |
| Unlabelled mononuclear cells | Placebo comparator | Not described Receives: Other: Infusion of investigational product; Other: Cardiac magnetic resonance imaging |
| SPIO alone | Active comparator | Not described Receives: Other: Infusion of investigational product; Other: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells.
Measured: 90 days
Secondary outcomes (1)
Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- David E Newby, MD, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127113
- Sponsor's protocol ID
- EDO001
- Status last verified
- Dec 2014
- First submitted
- 13 Apr 2010
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cell Labelling and Tracking With Magnetic Resonance Imaging After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01127113
- Acronym / sponsor ID
- EDO001
- Conditions
- Myocardial Infarction, Inflammation
- Keywords
- Myocardial infarction, Magnetic resonance imaging, Nanoparticles, Mononuclear cells, Cell tracking
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jan 2010
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 May 2010 (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.
Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty 'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a blood clot and blockage of the artery. The heart muscle normally supplied by the artery becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of the heart muscle damage is caused by overactivation of inflammatory cells. Whilst inflammation can be beneficial in healing processes, there is accumulating evidence that overactivation of inflammatory processes contributes to further muscle damage and cell death during myocardial infarction. We have recently developed a means of labelling human blood cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood to allow the cells to be tracked and seen in the body using a conventional magnetic resonance scanner.
In the proposed study we aim to recruit patients with recent heart attacks to perform similar cell labelling and reinjection of labelled cells into the same volunteer's blood stream via the arm to track the fate of the blood cells over the course of days to months. We think that the labelled inflammatory cells will 'home' to the site of the heart attack and will be visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the role of inflammatory cells in myocardial infarction, but also propose that, if successful, this technique could be used in the future to assess the effects of antiinflammatory treatments currently being developed for the treatment of patients with heart attacks. The technique could also be extended to allow labelling of other cell types, including stem cells, to let us further understand how these cells may contribute to repair of damaged organs including the heart.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPIO-labelled mononuclear cells | Active comparator | Other: Infusion of investigational product, Other: Cardiac magnetic resonance imaging |
| Unlabelled mononuclear cells | Placebo comparator | Other: Infusion of investigational product, Other: Cardiac magnetic resonance imaging |
| SPIO alone | Active comparator | Other: Infusion of investigational product, Other: Cardiac magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presentation with acute ST segment elevation myocardial infarction:
- Successful treatment with primary percutaneous coronary intervention Restoration of TIMI grade 3 flow in infarct-related artery
- Troponin I ≥10 IU/mL at 12 hours after the onset of chest pain
- Age 18 - 80 years
Key exclusion criteria (10 listed)
- Left main stem or severe multi-vessel coronary artery disease
- Continued symptoms of angina at rest or minimal exertion
- Atrial fibrillation
- Symptomatic heart failure; Killip Class ≥2.
- Hepatic or renal failure (estimated glomerular filtration rate <25 mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of investigational productAlso: The investigational product will be either:, 1) Unlabelled autologous mononuclear cells, 2) Endorem (Guerbet, Paris) contrast alone, 3) Autologous mononuclear cells labelled with EndoremThe investigational product will be delivered via intravenous infusion | Other | SPIO alone, SPIO-labelled mononuclear cells, Unlabelled mononuclear cells |
| Cardiac magnetic resonance imagingCardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after. | Other | SPIO alone, SPIO-labelled mononuclear cells, Unlabelled mononuclear cells |
Primary outcome
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells.
Time frame: 90 days
1 secondary outcome
Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation.
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Related trials for Myocardial Infarction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
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.
David E Newby, MD, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion of investigational product and Cardiac magnetic resonance imaging in people with Myocardial Infarction and Inflammation, run by University of Edinburgh at 1 site in United Kingdom.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2024.