3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy

April 27, 2015 updated by: Papworth Hospital NHS Foundation Trust

Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy

Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

51

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery

Description

Inclusion Criteria:

  • Adult patients
  • undergoing pulmonary endarterectomy surgery at Papworth Hospital
  • Willing to provide informed consent

Exclusion Criteria:

  • Patient refusal
  • Contraindication to transoesophageal echocardiography
  • Technical difficulty preventing adequate echocardiographic assessment of right heart function

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary Endarterectomy patients
Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital
Procedure: Pulmonary endarterectomy
Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.
Other Names:
  • Transoesophageal Echocardiography
  • Transthoracic Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular ejection fraction
Time Frame: 6 months
3-dimensional acquisition of right ventricular ejection fraction using echocardiography
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tricuspid annular plane systolic excursion
Time Frame: 6 months
6 months
Right ventricular fractional area change
Time Frame: 6 months
6 months
Right ventricular strain
Time Frame: 6 months
6 months
Pulmonary artery acceleration time
Time Frame: 6 months
6 months
Left ventricular ejection fraction
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Andrew J Roscoe, FRCA, Papworth Hospital NHS Foundation Trust

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

May 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02016

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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