STEMINCT02791178
Optical Coherence Tomography in STEMI
An observational study of STEMI, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
The overall objective of this research proposal is to use OCT to investigate those morphological culprit plaque characteristics associated with the risk of developing MVO in reperfused STEMI patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- STEMI
- What is being tested?
- Optical coherence tomography (OCT), Index of microcirculatory resistance (IMR) and Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2016to Jan 2018
- 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: The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study.
Who may be able to join
- Confirmed STEMI as per the in-charge consultant based on presenting history, ECG and angiogram findings.
- < 12 hours of onset of chest pain.
- Ability to provide informed consent
Who cannot join
- Previous myocardial infarction or coronary artery bypass graft surgery
- Cardiac arrest or cardiogenic shock
- Inability to advance the OCT catheter or to obtain good image quality
- Ostial lesions
- Significant renal impairment
- Contraindications for cardiac MRI
- Contraindication for adenosine (for IMR measurement)
Trial locations and contacts
1 site in 1 country.
Derek Hausenloy contact
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
Official title: Plaque Evaluation by Optical Coherence Tomography and Its Association With Microvascular Obstruction in Reperfused STEMI Patients - The POMS Study
The overall objective of this research proposal is to use OCT to investigate those morphological culprit plaque characteristics associated with the risk of developing MVO in reperfused STEMI patients.
Read the detailed description
The specific research objectives include:
- To use OCT to determine the type of plaque (plaque rupture, plaque erosion or calcified nodule) most associated with the presence and severity of MVO (as measured by IMR and cardiac MRI).
- To use OCT to investigate the relationship between the extent of tissue protrusion and the amount of residual stent thrombus with the presence and severity of MVO (as measured by IMR and cardiac MRI).
- Conditions
- STEMI
- Being tested
- Optical coherence tomography (OCT), Index of microcirculatory resistance (IMR), Cardiac MRI
- 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.
Optical coherence tomography (OCT)Procedure or surgery
Special camera to study part of your heart that was affected
Index of microcirculatory resistance (IMR)Procedure or surgery
Special wire to study part of your heart that was affected
Cardiac MRIOther
Special scanner if the heart to assess the damage of your heart
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study.
All patients to do Optical Coherence Tomography (OCT), Index of Microcirculatory Resistance (IMR) and Cardiac MRI. Receives: Procedure: Optical coherence tomography (OCT); Procedure: Index of microcirculatory resistance (IMR); Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: Two years
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 startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Hausenloy, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791178
- Sponsor's protocol ID
- 2015/3034
- 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
- Plaque Evaluation by Optical Coherence Tomography and Its Association With Microvascular Obstruction in Reperfused STEMI Patients - The POMS Study
- ClinicalTrials.gov ID
- NCT02791178
- Acronym / sponsor ID
- 2015/3034
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (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.
The overall objective of this research proposal is to use OCT to investigate those morphological culprit plaque characteristics associated with the risk of developing MVO in reperfused STEMI patients.
Detailed description
The specific research objectives include:
- To use OCT to determine the type of plaque (plaque rupture, plaque erosion or calcified nodule) most associated with the presence and severity of MVO (as measured by IMR and cardiac MRI).
- To use OCT to investigate the relationship between the extent of tissue protrusion and the amount of residual stent thrombus with the presence and severity of MVO (as measured by IMR and cardiac MRI).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | Procedure: Optical coherence tomography (OCT), Procedure: Index of microcirculatory resistance (IMR), Other: Cardiac MRIThe patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study. All patients to do Optical Coherence Tomography (OCT), Index of Microcirculatory Resistance (IMR) and Cardiac MRI. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study.
Key inclusion criteria (3 listed)
- Confirmed STEMI as per the in-charge consultant based on presenting history, ECG and angiogram findings.
- < 12 hours of onset of chest pain.
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Previous myocardial infarction or coronary artery bypass graft surgery
- Cardiac arrest or cardiogenic shock
- Inability to advance the OCT catheter or to obtain good image quality
- Ostial lesions
- Significant renal impairment
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 |
|---|---|---|
| Optical coherence tomography (OCT)Special camera to study part of your heart that was affected | Procedure or surgery | STEMI patients |
| Index of microcirculatory resistance (IMR)Special wire to study part of your heart that was affected | Procedure or surgery | STEMI patients |
| Cardiac MRISpecial scanner if the heart to assess the damage of your heart | Other | STEMI patients |
Primary outcome
All cause mortality
Time frame: Two years
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
Related trials for STEMI
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Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
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Breisgau PHENO-HEART MI
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Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
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RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
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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.
Derek Hausenloy contact
Derek Hausenloy 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 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: 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: Two years). 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.