Coronary CT Angiography in Non ST-elevation Myocardial Infarction

Non-ST Elevated Myocardial Infarction Clinical Trial

— CT-NSTEMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537741
• Other study ID #: 45965
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2020
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: St. Olavs Hospital
• Contact: Rune Wiseth, prof dr md
• Phone: +47 72828145
• Email: rune.wiseth[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Intervention

Procedure:
• Coronary CT angiography
all patients being included will undergo CCTA before invasive coronary angiography
• Invasive coronary angiography
all patients being included will undergo CCTA before invasive coronary angiography

Locations

Country	Name	City	State
Norway	Ålesund Hospital, Cardiac Unit	Ålesund
Norway	Kristiansund Hospital, Cardiac Unit	Kristiansund
Norway	Levanger Hospital, Cardiac Unit	Levanger
Norway	Molde Hospital, Cardiac Unit	Molde
Norway	Namsos Hospital, Cardiac Unit	Namsos
Norway	Orkdal Hospital, Cardiac Unit	Orkdal
Norway	St Olavs Hospital Clinic of Cardiology	Trondheim
Norway	Volda Hospital, Cardiac Unit	Volda

Sponsors (8)

Lead Sponsor	Collaborator
St. Olavs Hospital	Alesund Hospital, Helse Nord-Trøndelag HF, Kristiansund Hospital, Molde Hospital, Namsos Hospital, Norwegian University of Science and Technology, Volda Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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