Coronary CT Angiography in Non ST-elevation Myocardial Infarction
- Conditions
- Non-ST Elevated Myocardial Infarction
- Interventions
- Procedure: Coronary CT angiographyProcedure: Invasive coronary angiography
- Registration Number
- NCT04537741
- Lead Sponsor
- St. Olavs Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NSTEMI scheduled for angiography Coronary CT angiography - NSTEMI scheduled for angiography Invasive coronary angiography -
- Primary Outcome Measures
Name Time Method The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR 1 month For the primary endpoint analysis will be performed on patient level
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Kristiansund Hospital, Cardiac Unit
🇳🇴Kristiansund, Norway
Levanger Hospital, Cardiac Unit
🇳🇴Levanger, Norway
Molde Hospital, Cardiac Unit
🇳🇴Molde, Norway
Namsos Hospital, Cardiac Unit
🇳🇴Namsos, Norway
Orkdal Hospital, Cardiac Unit
🇳🇴Orkdal, Norway
St Olavs Hospital Clinic of Cardiology
🇳🇴Trondheim, Norway
Volda Hospital, Cardiac Unit
🇳🇴Volda, Norway
Ålesund Hospital, Cardiac Unit
🇳🇴Ålesund, Norway