Coronary CT Angiography in Non ST-elevation Myocardial Infarction

NCT04537741 | Active Not Recruiting

• 1 other identifier: 45965
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-ST Elevated Myocardial Infarction

Keywords

Coronary angiography; Angiography, CT; NSTEMI; CCTA; CT-FFR

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NSTEMI scheduled for angiography

EXPERIMENTAL

Procedure: Coronary CT angiography; Procedure: Invasive coronary angiography

Interventions

Coronary CT angiography PROCEDURE

all patients being included will undergo CCTA before invasive coronary angiography

NSTEMI scheduled for angiography

Invasive coronary angiography PROCEDURE

all patients being included will undergo CCTA before invasive coronary angiography

NSTEMI scheduled for angiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Namsos Hospital: collaborator
• Volda Hospital: collaborator
• Kristiansund Hospital: collaborator
• Molde Hospital: collaborator
• Alesund Hospital: collaborator

Study Sites (8)

Ålesund Hospital, Cardiac Unit

Ålesund, Norway

Location

Kristiansund Hospital, Cardiac Unit

Kristiansund, Norway

Location

Levanger Hospital, Cardiac Unit

Levanger, Norway

Location

Molde Hospital, Cardiac Unit

Molde, Norway

Location

Namsos Hospital, Cardiac Unit

Namsos, Norway

Location

Orkdal Hospital, Cardiac Unit

Orkdal, Norway

Location

St Olavs Hospital Clinic of Cardiology

Trondheim, Norway

Location

Volda Hospital, Cardiac Unit

Volda, Norway

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rune Wiseth, prof dr md

  St Olavs Hospital, Clinic of Cardiology

  STUDY DIRECTOR

• Øystein Risa

  Norwegian University of Science and Technology, ISB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: CCTA will be analysed at a core lab with no information of the results from invasive angiography or whether coronary revascularization was performed or not.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study where all patients being included will undergo CCTA before invasive coronary angiography

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: October 24, 2020
• Primary Completion: May 31, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (8)