STEMINCT01468662
CMR Repeatability in STEMI
An observational study of STEMI, run by University of Bristol at 1 site in United Kingdom.
Trial summary
The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- STEMI
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Apr 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: ST segment elevation myocardial infarction
Who may be able to join
- Participant may enter study if ALL of the following apply
- ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with >1 mm ST-segment elevation, or >2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and > 20 minutes of cardiac chest pain
- Written informed consent
Who cannot join
- Participant may not enter study if ANY of the following apply
- Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
- Known allergy to gadolinium
- Chronic atrial fibrillation
- Renal impairment with eGFR <30
- Cardiogenic shock
- Patients with special communication needs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Magnetic Resonance Scan Repeatability in ST Segment Elevation Myocardial Infarction
The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.
- Conditions
- STEMI
- Medical subject headings
- ST Elevation 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 |
|---|---|---|
| STEMI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer, intra-observer and inter-scan variability and agreement
Measured: Between 2 scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 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 STEMIStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa McAlindon, University of Bristol
- Investigators
- Elisa McAlindon, BMBS, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468662
- Sponsor's protocol ID
- Study 1569
- Status last verified
- Oct 2014
- First submitted
- 7 Nov 2011
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McAlindon EJ, Pufulete M, Harris JM, Lawton CB, Moon JC, Manghat N, Hamilton MC, Weale PJ, Bucciarelli-Ducci C. Measurement of myocardium at risk with cardiovascular MR: comparison of techniques for edema imaging. Radiology. 2015 Apr;275(1):61-70. doi: 10.1148/radiol.14131980. Epub 2014 Oct 21.
PubMed 25333474
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Magnetic Resonance Scan Repeatability in ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01468662
- Acronym / sponsor ID
- Study 1569
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- First posted
- 9 Nov 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 investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ST segment elevation myocardial infarction
Key inclusion criteria (3 listed)
- Participant may enter study if ALL of the following apply
- ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with >1 mm ST-segment elevation, or >2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and > 20 minutes of cardiac chest pain
- Written informed consent
Key exclusion criteria (7 listed)
- Participant may not enter study if ANY of the following apply
- Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
- Known allergy to gadolinium
- Chronic atrial fibrillation
- Renal impairment with eGFR <30
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
Inter-observer, intra-observer and inter-scan variability and agreement
Time frame: Between 2 scans
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 28 Oct 2014.
- Derived from this study: PubMed 25333474McAlindon EJ, Pufulete M, Harris JM, Lawton CB, Moon JC, Manghat N, Hamilton MC, Weale PJ, Bucciarelli-Ducci C. Measurement of myocardium at risk with cardiovascular MR: comparison of techniques for edema imaging. Radiology. 2015 Apr;275(1):61-70. doi: 10.1148/radiol.14131980. Epub 2014 Oct 21.
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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.
Elisa McAlindon, BMBS principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by University of Bristol 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 3 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 28 Oct 2014. 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. 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?
Inter-observer, intra-observer and inter-scan variability and agreement (time frame: Between 2 scans). 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 NCT01468662, 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 28 Oct 2014.