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Coronary CT Angiography in Non ST-elevation Myocardial Infarction

Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04537741
Acronym
CT-NSTEMI
Enrollment
300
Registered
2020-09-03
Start date
2020-10-24
Completion date
2027-06-30
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST Elevated Myocardial Infarction

Keywords

Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR

Brief 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. 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.

Interventions

all patients being included will undergo CCTA before invasive coronary angiography

all patients being included will undergo CCTA before invasive coronary angiography

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
Helse Nord-Trøndelag HF
CollaboratorOTHER
Namsos Hospital
CollaboratorOTHER
Volda Hospital
CollaboratorOTHER
Kristiansund Hospital
CollaboratorOTHER
Molde Hospital
CollaboratorOTHER
Alesund Hospital
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

CCTA will be analysed at a core lab with no information of the results from invasive angiography or whether coronary revascularization was performed or not.

Intervention model description

Single arm study where all patients being included will undergo CCTA before invasive coronary angiography

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR1 monthFor the primary endpoint analysis will be performed on patient level

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026