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Active, Not Recruiting

NCT Number: NCT04537741

Coronary CT Angiography in Non ST-elevation Myocardial Infarction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristiansund Hospital, Cardiac Unit, Kristiansund, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary CT Angiography

Procedure

all patients being included will undergo CCTA before invasive coronary angiography

invasive coronary angiography

Procedure

all patients being included will undergo CCTA before invasive coronary angiography

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

    Time frame: 1 month

    For the primary endpoint analysis will be performed on patient level

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Alesund Hospital
  • Helse Nord-Trøndelag HF
  • Kristiansund Hospital
  • Molde Hospital
  • Namsos Hospital
  • Norwegian University of Science and Technology
  • Volda Hospital

Registry information

Official study title

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

Acronym: CT-NSTEMI

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Sep 3, 2020
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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