Coronary CT Angiography in Non ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-ST Elevated Myocardial Infarction

Intervention / Treatment
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* Procedure: Coronary CT angiography
* Procedure: Invasive coronary angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm study where all patients being included will undergo CCTA before invasive coronary angiography
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSTEMI scheduled for angiography<br> | Procedure: Coronary CT angiography<br>* all patients being included will undergo CCTA before invasive coronary angiography<br>Procedure: Invasive coronary angiography<br>* all patients being included will undergo CCTA before invasive coronary angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR