STEMINCT02791165
Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient
An observational study of STEMI, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- STEMI
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2015to Jan 2017
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with an acute STEMI
Who may be able to join
- Confirmed STEMI as per PPCI procedure reports/ clinical notes
- Proximal to mid coronary artery occlusion.
- Ability to provide informed consent
Who cannot join
- Previous myocardial infarction or coronary artery bypass graft surgery
- Contraindication for CMR (e.g. ferromagnetic implants, claustrophobia, estimated glomerular filtration rate <30mL/min)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, Singapore, 169609
Mung Peng, 6704 ext. 2267, wong.mung.peng@nhcs.com.sg
Derek Hausenloy
About this study
There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute reperfused STEMI in order to identify the optimal day for performing the CMR scan.
Read the detailed description
This will be a prospective observational study with serial CMR imaging only.
CMR scan Each patient will receive one CMR scan performed on Day 1, Day 3, Day 5, Day 10 following the PPCI procedure on a 3T Philips scanner (see study flow below). All CMR scans will be analysed at a central CMR corelab.
For Day 1, 3, 5, 7 and 10 CMRs, parameters will be collected as follows:
- Left ventricle (LV) ejection fraction and indexed LV end systolic and diastolic volumes and mass using short-axis SSFP cine imaging and myocardial tagging sequences).
- The AAR by T1 and T2 mapping18 as a percentage of the LV over time.
- Signal intensity of T1 and T2 mapping in the MI zone, MI core and remote myocardium over time.
- The incidence of intramyocardial haemorrhage (IMH)(hypo-enhancement on T2* mapping sequence)26.
- The volume of microvascular obstruction (MVO) defined as signal intensity 2 standard deviated below the mean signal intensity of the remote myocardium on the T2* maps.
Additional sequence for Day 3 and 7 CMR scans:
- All the above plus MI size (measured in mass of LGE and expressed as a percentage of the LV mass).
- Conditions
- STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- National Heart Centre Singapore, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791165
- Sponsor's protocol ID
- 2015/3033
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient
- ClinicalTrials.gov ID
- NCT02791165
- Acronym / sponsor ID
- 2015/3033
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 6 Jun 2016 (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.
There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute reperfused STEMI in order to identify the optimal day for performing the CMR scan.
Detailed description
This will be a prospective observational study with serial CMR imaging only.
CMR scan Each patient will receive one CMR scan performed on Day 1, Day 3, Day 5, Day 10 following the PPCI procedure on a 3T Philips scanner (see study flow below). All CMR scans will be analysed at a central CMR corelab.
For Day 1, 3, 5, 7 and 10 CMRs, parameters will be collected as follows:
- Left ventricle (LV) ejection fraction and indexed LV end systolic and diastolic volumes and mass using short-axis SSFP cine imaging and myocardial tagging sequences).
- The AAR by T1 and T2 mapping18 as a percentage of the LV over time.
- Signal intensity of T1 and T2 mapping in the MI zone, MI core and remote myocardium over time.
- The incidence of intramyocardial haemorrhage (IMH)(hypo-enhancement on T2* mapping sequence)26.
- The volume of microvascular obstruction (MVO) defined as signal intensity 2 standard deviated below the mean signal intensity of the remote myocardium on the T2* maps.
Additional sequence for Day 3 and 7 CMR scans:
- All the above plus MI size (measured in mass of LGE and expressed as a percentage of the LV mass).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with an acute STEMI
Key inclusion criteria (3 listed)
- Confirmed STEMI as per PPCI procedure reports/ clinical notes
- Proximal to mid coronary artery occlusion.
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Previous myocardial infarction or coronary artery bypass graft surgery
- Contraindication for CMR (e.g. ferromagnetic implants, claustrophobia, estimated glomerular filtration rate <30mL/min)
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
All cause mortality
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Individual participant dataSharing planned: No
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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.
National Heart Centre Singapore principal investigator
National Heart Centre Singapore
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 National Heart Centre Singapore at 1 site in Singapore.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2016. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mung Peng (6704 ext. 2267, wong.mung.peng@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: One year). 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 6 Jun 2016.