CT-NSTEMI: Coronary CT Angiography in Non ST-elevation Myocardial Infarction

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04537741
• Collaborator: Norwegian University of Science and Technology (Other), Helse Nord-Trøndelag HF (Other), Namsos Hospital (Other), Volda Hospital (Other), Kristiansund Hospital (Other), Molde Hospital (Other), Alesund Hospital (Other)
• Enrollment: 300
• Locations: 8
• Arm: 1
• Anticipated Duration (Months): 35.2
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-ST Elevated Myocardial Infarction	Procedure: Coronary CT angiography; Procedure: Invasive coronary angiography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm study where all patients being included will undergo CCTA before invasive coronary angiographySingle arm study where all patients being included will undergo CCTA before invasive coronary angiography
• Masking: None (Open Label)
• Masking Description: 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.
• Primary Purpose: Diagnostic
• Official Title: Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
• Actual Study Start Date: Oct 24, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR [1 month]

   For the primary endpoint analysis will be performed on patient level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kristiansund Hospital, Cardiac Unit	Kristiansund		Norway
2	Levanger Hospital, Cardiac Unit	Levanger		Norway
3	Molde Hospital, Cardiac Unit	Molde		Norway
4	Namsos Hospital, Cardiac Unit	Namsos		Norway
5	Orkdal Hospital, Cardiac Unit	Orkdal		Norway
6	St Olavs Hospital Clinic of Cardiology	Trondheim		Norway
7	Volda Hospital, Cardiac Unit	Volda		Norway
8	Ålesund Hospital, Cardiac Unit	Ålesund		Norway

Sponsors and Collaborators

• St. Olavs Hospital
• Norwegian University of Science and Technology
• Helse Nord-Trøndelag HF
• Namsos Hospital
• Volda Hospital
• Kristiansund Hospital
• Molde Hospital
• Alesund 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT04537741
• Other Study ID Numbers: 45965
• First Posted: Sep 3, 2020
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by St. Olavs Hospital: Coronary angiography; Angiography, CT; NSTEMI; CCTA; CT-FFR
• Additional relevant MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction

Study Results

No Results Posted as of Nov 30, 2021