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

NCT ID: NCT02426203

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Endarterectomy patients

Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital

Pulmonary endarterectomy

Intervention Type PROCEDURE

Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Interventions

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Pulmonary endarterectomy

Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Intervention Type PROCEDURE

Other Intervention Names

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Transoesophageal Echocardiography Transthoracic Echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew J Roscoe, FRCA

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Foundation Trust

Central Contacts

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James E Moore, FANZCA FCICM

Role: CONTACT

44 1480 830 541

Andrew A Klein, FRCA FFICM

Role: CONTACT

44 1480 830 541

Other Identifiers

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P02016

Identifier Type: -

Identifier Source: org_study_id

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