Coronary CT Angiography in Non ST-elevation Myocardial Infarction (CT-NSTEMI)

St. Olavs Hospital

Status: Active, not recruiting

Conditions: Non-ST Elevated Myocardial Infarction

Treatments: Procedure: Coronary CT angiography; Procedure: Invasive coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04537741

45965

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

NSTEMI scheduled for angiography

Experimental group

Treatment:

Procedure: Invasive coronary angiography

Procedure: Coronary CT angiography