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NCT04907786

CCTA-guided Ultraselective Invasive Coronary Angiography

Status unknown Last updated 3 August 2021
What this trial tests

trial in Coronary Artery Disease in 250 participants. Status unknown.

Timeline
1 July 2021
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorCatharina Ziekenhuis Eindhoven
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment250
Start date1 July 2021
Primary completion31 December 2022
Estimated completion31 December 2022
Sites1 location across Netherlands

Conditions studied

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

Adults 18 to 80, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronary artery disease (CAD) is the leading cause of death in adults in the United States.\[1\] In the latest guidelines of the European Society of Cardiology anatomical non-invasive imaging by coronary computed tomography angiography (CCTA) plays an important role in the diagnosis of the presence of CAD in patients without a history of CAD and a low to intermediate likelihood.\[2\] CCTA provides high accuracy for the detection of coronary artery disease by visualizing the coronary artery lumen using an intravenous contrast agent.\[3\] However to determine the hemodynamical significance of CCTA-identified stenosis, invasive coronary angiography (ICA) with or without functional testing is still required. \[4\] During the ICA as per protocol the complete coronary artery system is visualized again. In patients with abnormalities on CCTA in only one coronary artery, i.e. only the left coronary artery (LCA) or the right coronary artery (RCA), the ICA procedure might be simplified by 'ultraselectively' visualizing only the coronary artery of interest and refraining from angiographic visualization of the contralateral coronary artery without abnormalities on CCTA (with an excellent negative predictive value of 95-99%).\[5-7\] Such an ultraselective strategy might reduce procedure time, usage of catheters, complication risk and the amount of contrast agent and radiation exposure. A recent retrospective study in three hospitals in the Netherlands showed CCTA to be extremely accurate in predicting a normal contralateral coronary artery in patients with coronary artery disease limited to the left or right coronary artery. Therefore, a CCTA-guided ultraselective ICA approach would have been safe and feasible and would have led to a considerable decrease in procedure time and radiation exposure. However, the analysis was hampered by the retrospective design. The potential benefits in salvage of procedure time and radiation exposure might be overestimated and it turned out to be impossible to measure the effects on contrast use, catheter use and procedure costs. Moreover, in the retrospective study only a small portion of the study population had abnormalities in the right coronary artery, thereby questioning the results of this study to safely be extrapolated to this category of patients with abnormalities in the RCA. This dual-center prospective registry study is designed to answer these remaining questions and to further investigate the potential benefit of an ultraselective ICA approach.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Coronary Artery Disease

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Data sources for this page

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