Non-ST Elevated Myocardial InfarctionCT-NSTEMINCT04537741
Coronary CT Angiography in Non ST-elevation Myocardial Infarction
A study testing Coronary CT angiography and Invasive coronary angiography in people with Non-ST Elevated Myocardial Infarction, run by St. Olavs Hospital at 8 sites in Norway.
Trial summary
Non ST-elevation myocardial infarction (NSTEMI) represents 70-75% of all myocardial infarctions. Current guidelines recommend invasive angiography and this patient group represents a major burden on the invasive catheterization laboratories and the health care system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-ST Elevated Myocardial Infarction
- What is being tested?
- Coronary CT angiography and Invasive coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesNorway
- Study dates
- 24 Oct 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to a local hospital with NSTEMI type 1 or type 2 based on clinical criteria
- indication for invasive coronary angiography according to current guidelines
Who cannot join
- indication for immediate (< 2 hours) invasive strategy according to guidelines
- GRACE score > 140
- not willing to provide written informed consent
- previous coronary revascularization
- estimated glomerular filtration rate < 30 mL/min/1,73m2
- allergic reactions to contrast agents impeding for safe examinations
- > 2 hypokinetic segments on echocardiography
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Ålesund Hospital, Cardiac Unit
Ålesund
Kristiansund Hospital, Cardiac Unit
Kristiansund
Levanger Hospital, Cardiac Unit
Levanger
Molde Hospital, Cardiac Unit
Molde
Namsos Hospital, Cardiac Unit
Namsos
Orkdal Hospital, Cardiac Unit
Orkdal
St Olavs Hospital Clinic of Cardiology
Trondheim
Volda Hospital, Cardiac Unit
Volda
About this study
Official title: Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
Non ST-elevation myocardial infarction (NSTEMI) represents 70-75% of all myocardial infarctions. Current guidelines recommend invasive angiography and this patient group represents a major burden on the invasive catheterization laboratories and the health care system.
The coronary pathology found in NSTEMI-patients varies substantially, ranging from structurally normal vessels, non-obstructive atherosclerosis to severe multivessel disease. 30-40 % of patients with NSTEMI undergoing invasive coronary angiography do not undergo revascularization. If these patients could be identified by a non-invasive method like coronary CT angiography (CCTA), an invasive procedure with the potential risk for complications could be avoided. Furthermore, less patients would need transfer to an invasive center. Both for patients and for health care costs this would be of major benefit.
Read more
The quality of CCTA images has improved during the years, and radiation dose has decreased. Due to technological development it is now possible to perform high quality coronary CCTA with a very low radiation dose (1-1.5 mSv) compared to a radiation dose of 3-4 mSv for invasive coronary angiography.
The overall aim of the project is to define a subpopulation of NSTEMI patients that preferably should undergo CCTA as the first step in imaging of the coronary arteries and thus potentially be saved from an unnecessary invasive investigation. This would result in less patient discomfort, less patient risk and reduced health care costs. Patients with a clinical indication for invasive angiography according to current guidelines will undergo CCTA prior to the invasive investigation. The ability of CCTA to identify those with no need for revascularization will be assessed using invasive angiography as the gold standard.
- Conditions
- Non-ST Elevated Myocardial Infarction
- Being tested
- Coronary CT angiography, Invasive coronary angiography
- Keywords
- Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR
- 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.
Coronary CT angiographyProcedure or surgery
all patients being included will undergo CCTA before invasive coronary angiography
Invasive coronary angiographyProcedure or surgery
all patients being included will undergo CCTA before invasive coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI scheduled for angiography | Experimental | Not described Receives: Procedure: Coronary CT angiography; Procedure: Invasive coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
For the primary endpoint analysis will be performed on patient level
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start24 Oct 2020
- Primary completion31 May 2024
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study where all patients being included will undergo CCTA before invasive coronary angiography
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Nord-Trøndelag HF, Namsos Hospital, Volda Hospital, Kristiansund Hospital, Molde Hospital, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Rune Wiseth, prof dr md, Study director, St Olavs Hospital, Clinic of CardiologyØystein Risa, Study director, Norwegian University of Science and Technology, ISB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537741
- Sponsor's protocol ID
- 45965
- Acronym
- CT-NSTEMI
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2020
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
- ClinicalTrials.gov ID
- NCT04537741
- Acronym / sponsor ID
- CT-NSTEMI / 45965
- Conditions
- Non-ST Elevated Myocardial Infarction
- Keywords
- Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Nord-Trøndelag HF, Namsos Hospital, Volda Hospital, Kristiansund Hospital, Molde Hospital, Alesund Hospital
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Sep 2020 (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.
Non ST-elevation myocardial infarction (NSTEMI) represents 70-75% of all myocardial infarctions. Current guidelines recommend invasive angiography and this patient group represents a major burden on the invasive catheterization laboratories and the health care system.
The coronary pathology found in NSTEMI-patients varies substantially, ranging from structurally normal vessels, non-obstructive atherosclerosis to severe multivessel disease. 30-40 % of patients with NSTEMI undergoing invasive coronary angiography do not undergo revascularization. If these patients could be identified by a non-invasive method like coronary CT angiography (CCTA), an invasive procedure with the potential risk for complications could be avoided. Furthermore, less patients would need transfer to an invasive center. Both for patients and for health care costs this would be of major benefit.
The quality of CCTA images has improved during the years, and radiation dose has decreased. Due to technological development it is now possible to perform high quality coronary CCTA with a very low radiation dose (1-1.5 mSv) compared to a radiation dose of 3-4 mSv for invasive coronary angiography.
The overall aim of the project is to define a subpopulation of NSTEMI patients that preferably should undergo CCTA as the first step in imaging of the coronary arteries and thus potentially be saved from an unnecessary invasive investigation. This would result in less patient discomfort, less patient risk and reduced health care costs. Patients with a clinical indication for invasive angiography according to current guidelines will undergo CCTA prior to the invasive investigation. The ability of CCTA to identify those with no need for revascularization will be assessed using invasive angiography as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study where all patients being included will undergo CCTA before invasive coronary angiography
| Arm | Type | Receives |
|---|---|---|
| NSTEMI scheduled for angiography | Experimental | Procedure: Coronary CT angiography, Procedure: Invasive coronary angiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- admitted to a local hospital with NSTEMI type 1 or type 2 based on clinical criteria
- indication for invasive coronary angiography according to current guidelines
Key exclusion criteria (7 listed)
- indication for immediate (< 2 hours) invasive strategy according to guidelines
- GRACE score > 140
- not willing to provide written informed consent
- previous coronary revascularization
- estimated glomerular filtration rate < 30 mL/min/1,73m2
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 |
|---|---|---|
| Coronary CT angiographyall patients being included will undergo CCTA before invasive coronary angiography | Procedure or surgery | NSTEMI scheduled for angiography |
| Invasive coronary angiographyall patients being included will undergo CCTA before invasive coronary angiography | Procedure or surgery | NSTEMI scheduled for angiography |
Primary outcome
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
Time frame: 1 month
For the primary endpoint analysis will be performed on patient level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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.
Rune Wiseth, prof dr md study director
St Olavs Hospital, Clinic of Cardiology
Øystein Risa study director
Norwegian University of Science and Technology, ISB
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary CT angiography and Invasive coronary angiography in people with Non-ST Elevated Myocardial Infarction, run by St. Olavs Hospital at 8 sites in Norway.
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 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
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 number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR (time frame: 1 month). 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 11 Aug 2026.