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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Danish study of Non-Invasive Testing in Coronary Artery Disease 3 (Dan-NICAD 3): study design of a controlled study
Simon Winther1, Laust Dupont Rasmussen1, Jelmer Westra2
1Department of Cardiology, Gødstrup Hospital, Herning, Denmark.
Insights
This study compares two non-invasive imaging methods, Rubidium-82 PET and Oxygen-15 water PET, to accurately diagnose coronary artery disease (CAD) after coronary CTA. It aims to clarify the diagnostic value of selective myocardial perfusion imaging in patients with suspected obstructive CAD.
Area of Science:
- Cardiology
- Nuclear Medicine
- Diagnostic Imaging
Background:
- Current guidelines suggest functional imaging for myocardial ischemia when coronary CT angiography (CTA) reveals coronary artery disease (CAD) of uncertain significance.
- The diagnostic accuracy of myocardial perfusion imaging following coronary CTA is not well-established.
- This research addresses the need for clarity on non-invasive diagnostic tools for obstructive CAD.
Purpose of the Study:
- To evaluate and compare the diagnostic accuracy of Rubidium-82 PET (Rb-PET) and Oxygen-15 water PET (O-water-PET) for detecting obstructive coronary artery disease (CAD).
- To assess the utility of selective myocardial perfusion imaging after coronary CTA in symptomatic patients.
- To provide head-to-head comparison of two PET tracers against invasive coronary angiography.
Main Methods:
- A prospective, multicentre, cross-sectional study involving approximately 1000 symptomatic patients without prior CAD.
- Patients underwent coronary CTA, followed by both Rb-PET and O-water-PET if CTA suggested obstructive CAD.
- Comparison with invasive coronary angiography, including fractional flow reserve and coronary flow reserve measurements, was performed.
Main Results:
- Data collection and analysis are ongoing.
- The study is designed to yield definitive comparative diagnostic accuracy data for Rb-PET and O-water-PET.
- Long-term follow-up will assess cardiovascular events and patient-reported outcomes.
Conclusions:
- The study will clarify the diagnostic performance of Rb-PET and O-water-PET in identifying functionally significant coronary artery disease.
- Findings will inform clinical guidelines regarding the use of functional imaging after coronary CTA.
- This research contributes to optimizing non-invasive diagnostic strategies for patients with suspected obstructive CAD.
Introduction:
Current guideline recommend functional imaging for myocardial ischaemia if coronary CT angiography (CTA) has shown coronary artery disease (CAD) of uncertain functional significance. However, diagnostic accuracy of selective myocardial perfusion imaging after coronary CTA is currently unclear. The Danish study of Non-Invasive testing in Coronary Artery Disease 3 trial is designed to evaluate head to head the diagnostic accuracy of myocardial perfusion imaging with positron emission tomography (PET) using the tracers 82Rubidium (82Rb-PET) compared with oxygen-15 labelled water PET (15O-water-PET) in patients with symptoms of obstructive CAD and a coronary CT scan with suspected obstructive CAD.
Methods And Analysis:
This prospective, multicentre, cross-sectional study will include approximately 1000 symptomatic patients without previous CAD. Patients are included after referral to coronary CTA. All patients undergo a structured interview and blood is sampled for genetic and proteomic analysis and a coronary CTA. Patients with possible obstructive CAD at coronary CTA are examined with both 82Rb-PET, 15O-water-PET and invasive coronary angiography with three-vessel fractional flow reserve and thermodilution measurements of coronary flow reserve. After enrolment, patients are followed with Seattle Angina Questionnaires and follow-up PET scans in patients with an initially abnormal PET scan and for cardiovascular events in 10 years.
Ethics And Dissemination:
Ethical approval was obtained from Danish regional committee on health research ethics. Written informed consent will be provided by all study participants. Results of this study will be disseminated via articles in international peer-reviewed journal.
Trial Registration Number:
NCT04707859.
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