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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-ST Elevated Myocardial Infarction
• Intervention / Treatment: Procedure: Coronary CT angiography; Procedure: Invasive coronary angiography

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Kristiansund Hospital, Cardiac Unit
  • Levanger, Norway
    • Levanger Hospital, Cardiac Unit
  • Molde, Norway
    • Molde Hospital, Cardiac Unit
  • Namsos, Norway
    • Namsos Hospital, Cardiac Unit
  • Orkdal, Norway
    • Orkdal Hospital, Cardiac Unit
  • Trondheim, Norway
    • St Olavs Hospital Clinic of Cardiology
  • Volda, Norway
    • Volda Hospital, Cardiac Unit
  • Ålesund, Norway
    • Ålesund Hospital, Cardiac Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSTEMI scheduled for angiography	Procedure: Coronary CT angiography; all patients being included will undergo CCTA before invasive coronary angiography; Procedure: Invasive coronary angiography; all patients being included will undergo CCTA before invasive coronary angiography

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; Helse Nord-Trøndelag HF; Alesund Hospital; Namsos Hospital; Molde Hospital; Kristiansund Hospital; Volda Hospital
• Investigators: Study Director: Rune Wiseth, prof dr md, St Olavs Hospital, Clinic of Cardiology; Study Director: Øystein Risa, Norwegian University of Science and Technology, ISB

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2020
• Primary Completion (Actual): May 31, 2024
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Coronary angiography; NSTEMI; CT-FFR; CCTA; Angiography, CT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Non-ST Elevated Myocardial Infarction; Myocardial Infarction; Infarction
• Other Study ID Numbers: 45965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No