NSTEMI - Non-ST Segment Elevation MINS-CULPRITNCT03479593
Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)
An observational study of NSTEMI - Non-ST Segment Elevation MI and Multi Vessel Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSTEMI - Non-ST Segment Elevation MI, Multi Vessel Coronary Artery Disease
- What is being tested?
- CMR and OCT in NSTEMI patients with MVD
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2018to 1 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible NSTEMI patients scheduled for CAG at one center
Who may be able to join
- Patients > 18 years of age
- NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.
- Multivessel disease at CAG: More than one vessel with >50% stenosis.
Who cannot join
- Known intolerance of heparin or contrast medium.
- Inability to understand information or to provide informed consent.
- estimated glomerular filtration rate (eGFR) < 30 ml/min.
- Other reasons for troponin rise not applicable to acute myocardial infarction.
- Atrial fibrillation at admission.
- Patients with contraindication for CMR will only have OCT performed.
- Potential pregnancy
- Unstable patients requiring acute CAG and PCI
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Kathrine Ekström, MD, +4535452295, kathrine.ekstroem.01@regionh.dk
Thomas Engstrøm, DMSCi, PhD, +4535458444, thomas.engstroem@regionh.dk
About this study
Official title: Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
Read the detailed description
Background
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled.
Purpose
The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
Methods
The study employs cardiac magnetic resonance (CMR), which allows detection of myocardium exposed to even brief periods of ischemia. Furthermore, Optical Coherence Tomography (OCT) which visualises the coronary artery lumen and wall. OCT allows for direct visualization of atherosclerotic plaques, presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone.
Patients will have CMR performed prior to CAG. The PCI operator determines culprit based on CAG and ECG changes alone. OCT is subsequently performed on culprit lesion(s) and stenosis ≥ 50%.
Sample size calculation
Assuming the culprit lesion can be correctly identified with history/angiography/ECG in 95% of cases a positive predictive value >90% with 95% accuracy can be reached with 100 patients.
- Being tested
- CMR and OCT in NSTEMI patients with MVD
- Keywords
- NSTEMI, Culprit, Cardiac magnetic resonance, Optical Coherence Tomography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR and OCT in NSTEMI patients with MVDDiagnostic test
Lesions >50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography
| Study group | Role | What they receive |
|---|---|---|
| CMR and OCT in NSTEMI patients with MVD | NSTEMI patients with multi vessel disease Receives: Diagnostic Test: CMR and OCT in NSTEMI patients with MVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.
cross-tables will be used to calculate the positive predictive value Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG.
Measured: Through study completion, an average of 1 year
Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG
Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG. CMR is the golden standard.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start10 Jan 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMI - Non-ST Segment Elevation MIStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Engstrom, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas Engstrøm, DMSCi, PhD, Principal investigator, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479593
- Sponsor's protocol ID
- H-17023377
- Acronym
- NS-CULPRIT
- Status last verified
- Mar 2023
- First submitted
- 27 Nov 2017
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease
- ClinicalTrials.gov ID
- NCT03479593
- Acronym / sponsor ID
- NS-CULPRIT / H-17023377
- Keywords
- NSTEMI, Culprit, Cardiac magnetic resonance, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 27 Mar 2018 (actual)
- 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.
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
Detailed description
Background
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled.
Purpose
The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
Methods
The study employs cardiac magnetic resonance (CMR), which allows detection of myocardium exposed to even brief periods of ischemia. Furthermore, Optical Coherence Tomography (OCT) which visualises the coronary artery lumen and wall. OCT allows for direct visualization of atherosclerotic plaques, presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone.
Patients will have CMR performed prior to CAG. The PCI operator determines culprit based on CAG and ECG changes alone. OCT is subsequently performed on culprit lesion(s) and stenosis ≥ 50%.
Sample size calculation
Assuming the culprit lesion can be correctly identified with history/angiography/ECG in 95% of cases a positive predictive value >90% with 95% accuracy can be reached with 100 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR and OCT in NSTEMI patients with MVD | – | Diagnostic Test: CMR and OCT in NSTEMI patients with MVDNSTEMI patients with multi vessel disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible NSTEMI patients scheduled for CAG at one center
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.
- Multivessel disease at CAG: More than one vessel with >50% stenosis.
Key exclusion criteria (8 listed)
- Known intolerance of heparin or contrast medium.
- Inability to understand information or to provide informed consent.
- estimated glomerular filtration rate (eGFR) < 30 ml/min.
- Other reasons for troponin rise not applicable to acute myocardial infarction.
- Atrial fibrillation at admission.
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 |
|---|---|---|
| CMR and OCT in NSTEMI patients with MVDLesions >50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography | Diagnostic test | CMR and OCT in NSTEMI patients with MVD |
Primary outcome
Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
Time frame: Through study completion, an average of 1 year
Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test
2 secondary outcomes
Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.
Time frame: Through study completion, an average of 1 year
Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
Thomas Engstrøm, DMSCi, PhD principal investigator
Rigshospitalet, University of Copenhagen
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 NSTEMI - Non-ST Segment Elevation MI and Multi Vessel Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 8 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 29 Mar 2023. 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 Denmark. 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 Kathrine Ekström, MD (+4535452295, kathrine.ekstroem.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard) (time frame: Through study completion, an average of 1 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 29 Mar 2023.