Clinical trial NCT04537741: Coronary CT Angiography in Non ST-elevation Myocardial Infarction
Official title: Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-ST Elevated Myocardial Infarction
Keywords: Coronary angiography
Angiography, CT
NSTEMI
CCTA
CT-FFR
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Helse Nord-Trøndelag HF
name: Namsos Hospital
name: Volda Hospital
name: Kristiansund Hospital
name: Molde Hospital
name: Alesund Hospital
First posted: 2020-09-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study where all patients being included will undergo CCTA before invasive coronary angiography
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital, Cardiac Unit
city: Levanger
country: Norway
facility: Levanger Hospital, Cardiac Unit
city: Molde
country: Norway
facility: Molde Hospital, Cardiac Unit
city: Namsos
country: Norway
facility: Namsos Hospital, Cardiac Unit
city: Orkdal
country: Norway
facility: Orkdal Hospital, Cardiac Unit
city: Trondheim
country: Norway
facility: St Olavs Hospital Clinic of Cardiology
city: Volda
country: Norway
facility: Volda Hospital, Cardiac Unit
city: Ålesund
country: Norway
facility: Ålesund Hospital, Cardiac Unit
Study officials:
affiliation: St Olavs Hospital, Clinic of Cardiology
name: Rune Wiseth, prof dr md
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, ISB
name: Øystein Risa
role: STUDY_DIRECTOR
References: