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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI as an Indicator of Severe Aortic Regurgitation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient able to give informed consent to participate in the study
  • Patient with transthoracic echocardiography and MRI prescription

Exclusion Criteria:

  • Contraindication to MRI
  • Pathologies of the thoracic aorta (aneurism, dissection, stenosis)
  • Pathologies of the left subclavian artery (stenosis, narrowing)
  • Persistent arterial canal
  • Arteriovenous fistula of the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transthoracic echocardiography and MRI
The TransThoracic Echocardiography imaging data are collected exactly as for a standard examination. However, an additional measurement of the flow at the level of the left subclavian artery is performed, resulting in a 10-minute increase in the examination time. A Cardiovascular Magnetic Resonance Imaging 4D Flow is programmed within a maximum of 10 (no change in treatment that could skew the comparison). The usual procedure for MRI is not modified. The examination allows the acquisition of conventional 2D sequences of flow measurements, regurgitant volume and regurgitation fraction obtained at the level of the descending aorta and the sino-tubular junction of the ascending aorta. An additional 4D sequence is acquired increasing the examination time by 10 minutes.
Diagnostic test: transthoracic echocardiography
This involves the acquisition of 1 additional sequence: a 10-minute sequence for transthoracic echocardiography.
Diagnostic test: Cardiovascular Magnetic Resonance Imaging
This involves the acquisition of 1 additional sequence: a 10-minute sequence for Cardiovascular Magnetic Resonance Imaging 4D Flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of absence of reflux in the left subclavian artery in transthoracic echocardiography and MRI 4D flow
Time Frame: Day 1
It allows to evaluate the sensitivity/specificity of the presence of the left subclavian artery based holodiastolic regurgitation using transthoracic echocardiography on the one hand and 4D flow MRI on the other hand compared to the validated combined sonographic quantification criteria.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a tele-diastolic velocity threshold at the level of the left subclavian artery to quantify aortic regurgitation as severe by correlating the records with the other usual indices
Time Frame: Day 1
It allows tele-diastolic velocity measurement at the left subclavian artery
Day 1
Establish a speed ratio threshold (systolic peak / tele-diastolic velocity) at the aortic arch and left subclavian artery
Time Frame: Day 1
Diastolic / systolic speed ratio measurement at the left subclavian artery
Day 1
Evaluate the appearance of distal anterior interventricular flow and analyze its association with the severity of aortic leakage
Time Frame: Day 1
It allows to evaluate the changes in coronary flow morphology (diastolic / systolic velocity, and S / D ratio) in anterior interventricular during severe aortic regurgitation
Day 1
Evaluate the 4D flow MRI parameters
Time Frame: Day 1
It allows the measurement of regurgitant and anterograde volume in 4D flow MRI at the same sites as transthoracic echocardiography
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Olivier LOZINGUEZ, MD, Groupe hospitalier Paris saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

September 21, 2020

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUBCLAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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