Coronary CT Angiography in Non ST-elevation Myocardial Infarction (CT-NSTEMI)
Primary Purpose
Non-ST Elevated Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Coronary CT angiography
Invasive coronary angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-ST Elevated Myocardial Infarction focused on measuring Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR
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
Sites / Locations
- Kristiansund Hospital, Cardiac UnitRecruiting
- Levanger Hospital, Cardiac UnitRecruiting
- Molde Hospital, Cardiac UnitRecruiting
- Namsos Hospital, Cardiac UnitRecruiting
- Orkdal Hospital, Cardiac UnitRecruiting
- St Olavs Hospital Clinic of CardiologyRecruiting
- Volda Hospital, Cardiac UnitRecruiting
- Ålesund Hospital, Cardiac UnitRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NSTEMI scheduled for angiography
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04537741
First Posted
August 28, 2020
Last Updated
July 20, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Nord-Trøndelag HF, Namsos Hospital, Volda Hospital, Kristiansund Hospital, Molde Hospital, Alesund Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04537741
Brief Title
Coronary CT Angiography in Non ST-elevation Myocardial Infarction
Acronym
CT-NSTEMI
Official Title
Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Nord-Trøndelag HF, Namsos Hospital, Volda Hospital, Kristiansund Hospital, Molde Hospital, Alesund Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Elevated Myocardial Infarction
Keywords
Coronary angiography, Angiography, CT, NSTEMI, CCTA, CT-FFR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single 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.
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSTEMI scheduled for angiography
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Coronary CT angiography
Intervention Description
all patients being included will undergo CCTA before invasive coronary angiography
Intervention Type
Procedure
Intervention Name(s)
Invasive coronary angiography
Intervention Description
all patients being included will undergo CCTA before invasive coronary angiography
Primary Outcome Measure Information:
Title
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
Description
For the primary endpoint analysis will be performed on patient level
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rune Wiseth, prof dr md
Phone
+47 72828145
Email
rune.wiseth@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Synne M Sandberg
Email
synne.m.sandberg@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, prof dr md
Organizational Affiliation
St Olavs Hospital, Clinic of Cardiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Øystein Risa
Organizational Affiliation
Norwegian University of Science and Technology, ISB
Official's Role
Study Director
Facility Information:
Facility Name
Kristiansund Hospital, Cardiac Unit
City
Kristiansund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arild Dimmen
Email
Arild.Dimmen@helse-mr.no
Facility Name
Levanger Hospital, Cardiac Unit
City
Levanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Newton Andersen
Email
GarrettNewton.Andersen@helse-nordtrondelag.no
Facility Name
Molde Hospital, Cardiac Unit
City
Molde
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torgeir Sand-Aas
Email
Torgeir.Sand.Aas@helse-mr.no
Facility Name
Namsos Hospital, Cardiac Unit
City
Namsos
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathrine Sæthern
Email
Cathrine.Sethern.Rye@helse-nordtrondelag.no
Facility Name
Orkdal Hospital, Cardiac Unit
City
Orkdal
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petter Vanke
Email
petter.vanke@stolav.no
Facility Name
St Olavs Hospital Clinic of Cardiology
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, prof dr md
Email
rune.wiseth@ntnu.no
Facility Name
Volda Hospital, Cardiac Unit
City
Volda
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Synne M Sandberg
Email
synne.m.sandberg@ntnu.no
Facility Name
Ålesund Hospital, Cardiac Unit
City
Ålesund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva-Lill Rice
Email
Eva-Lill.Rice@helse-mr.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Coronary CT Angiography in Non ST-elevation Myocardial Infarction
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