NCT03549091: SUBCLAR

Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI

Status unknown NA Last updated 27 April 2023

What this trial tests

NA trial testing transthoracic echocardiography in Aortic Regurgitation in 70 participants. Status unknown.

Timeline

4 May 2018

Primary endpoint
21 September 2020

31 December 2023

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	4 May 2018
Primary completion	21 September 2020
Estimated completion	31 December 2023
Sites	1 location across France

Drugs / interventions tested

• transthoracic echocardiography
• Cardiovascular Magnetic Resonance Imaging

Conditions studied

• Aortic Regurgitation — all drugs for Aortic Regurgitation →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Aortic Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. The quantification of AI is therefore important as it can remain perfectly asymptomatic for a long time.

Doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. The quantification of IA requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. The recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. This makes it possible to evaluate with greater precision the importance of the leak. Thus, there is the difficulty of quantifying moderate and severe AI for lack of a truly unique criterion. One of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. The left subclavian artery (SCG) is more accessible than the aortic arch in terms of the ultrasound window. The measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. The quantification of the AI based on this new element will be compared to the other previously validated ultrasound criteria. The investigators will use this study to describe the feasibility of collecting coronary flow in the artery (IVA), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). The flows recorded in the IVA will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and MRI). The aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe AI (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac MRI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 4D flow cardiovascular magnetic resonance recovery profiles following pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension.
   Dong ML, Azarine A, Haddad F, Amsallem M, et al · · 2022 · cited 6× · PMID 36372884 · DOI 10.1186/s12968-022-00893-x