Coronary CT Angiography in Non ST-elevation Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-24

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-ST Elevated Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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NSTEMI scheduled for angiography

Group Type EXPERIMENTAL

Coronary CT angiography

Intervention Type PROCEDURE

all patients being included will undergo CCTA before invasive coronary angiography

Invasive coronary angiography

Intervention Type PROCEDURE

all patients being included will undergo CCTA before invasive coronary angiography

Interventions

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Coronary CT angiography

all patients being included will undergo CCTA before invasive coronary angiography

Intervention Type PROCEDURE

Invasive coronary angiography

all patients being included will undergo CCTA before invasive coronary angiography

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No