ST Segment Elevation Myocardial InfarctionNCT01897350
Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
An observational study of ST Segment Elevation Myocardial Infarction and Myocardial Oedema, run by Elisa McAlindon at 1 site in United Kingdom.
Trial summary
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction, Myocardial Oedema
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients will be undergo a CMR scan day 2 following STEMI
Who may be able to join
- STEMI
- providing written informed consent
Who cannot join
- contraindication to CMR,
- atrial fibrillation,
- claustrophobia,
- eGFR < 30
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.
- Being tested
- Cardiac magnetic resonance imaging
- Keywords
- STEMI, Myocardial edema, Cardiovascular magnetic resonance
- 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.
Cardiac magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| CMR following ST segment myocardial infarction | Not described Receives: Other: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mass of myocardial oedema measured by CMR
Measured: Day 2 following STEMI
Secondary outcomes (1)
Extra cellular volume
Measured: Day 2 following STEMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevation 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisa McAlindon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elisa McAlindon, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897350
- Sponsor's protocol ID
- Study 1953
- Status last verified
- Oct 2014
- First submitted
- 8 Jul 2013
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
- ClinicalTrials.gov ID
- NCT01897350
- Acronym / sponsor ID
- Study 1953
- Keywords
- STEMI, Myocardial edema, Cardiovascular magnetic resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elisa McAlindonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 12 Jul 2013 (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.
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR following ST segment myocardial infarction | – | Other: Cardiac magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients will be undergo a CMR scan day 2 following STEMI
Key inclusion criteria (2 listed)
- STEMI
- providing written informed consent
Key exclusion criteria (4 listed)
- contraindication to CMR,
- atrial fibrillation,
- claustrophobia,
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance imaging | Other | CMR following ST segment myocardial infarction |
Primary outcome
The mass of myocardial oedema measured by CMR
Time frame: Day 2 following STEMI
1 secondary outcome
Extra cellular volume
Time frame: Day 2 following STEMI
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 21 Oct 2014.
Related trials for ST Segment Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
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
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ST Segment Elevation Myocardial Infarction and Myocardial Oedema, run by Elisa McAlindon 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 2 inclusion and 4 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 21 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?
The mass of myocardial oedema measured by CMR (time frame: Day 2 following STEMI). 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 21 Oct 2014.