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Clinical Trials/NCT04537741
NCT04537741
Active, not recruiting
Not Applicable

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

St. Olavs Hospital8 sites in 1 country300 target enrollmentOctober 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-ST Elevated Myocardial Infarction
Sponsor
St. Olavs Hospital
Enrollment
300
Locations
8
Primary Endpoint
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2020
End Date
June 1, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR

Time Frame: 1 month

For the primary endpoint analysis will be performed on patient level

Study Sites (8)

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