An observational study in NSTEMI - Non-ST Segment Elevation MI and Multi Vessel Coronary Artery Disease, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Rigshospitalet, Denmark · Observational
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Among 10 studies in Non-ST Elevated Myocardial Infarction with a site in Denmark — 1 open to participants now, 4 under way, none of them phase 3. Non-ST Elevated Myocardial Infarction · Denmark.
Among the 10 studies in Non-ST Elevated Myocardial Infarction with a site in Denmark, this one is one of 2 that started in 2018, is one of 5 observational ones, and was the 5th registered.
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
Browse Non-ST Elevated Myocardial Infarction studies →1 of the 10 studies in Non-ST Elevated Myocardial Infarction with a site in Denmark is open now. Recruiting first, the newest first:
Rigshospitalet, Denmark · Sites in Denmark
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 40 Non-ST Elevated Myocardial Infarction studies recruiting now, 34 (85%) set no upper age limit and 1 (3%) stops at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 525 across 130 observational studies indexed under Non-ST Elevated Myocardial Infarction.
Median enrollment 3,503 across the 5 interventional studies, 225 across the 5 observational. Of the 3 that completed or were terminated, 3 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 10 have an industry lead sponsor. The 8 most frequent:
Rigshospitalet, Denmark is the lead sponsor of 1,006 studies on the registry; 174 are open to participants now.
Rigshospitalet, Denmark has 3 studies filed under Non-ST Elevated Myocardial Infarction — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Non-ST Elevated Myocardial Infarction with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Eligible NSTEMI patients scheduled for CAG at one center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NSTEMI patients with multi vessel disease
Diagnostic Test: CMR and OCT in NSTEMI patients with MVD
Lesions \>50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography
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
Time frame: Through study completion, an average of 1 year
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.
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
Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG. CMR is the golden standard.
Time frame: Through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jan 2022, 47 months.
Of 54 non-industry observational studies under Non-ST Elevated Myocardial Infarction, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 86. This study's 47 months is above that.
Counting every sponsor, half of 76 studies reached it within 32 months; a quarter within 19 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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