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

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ClinicalTrials.gov Identifier: NCT02426203
Recruitment Status : Unknown
Verified April 2015 by Papworth Hospital NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Tracking Information
First Submitted Date April 21, 2015
First Posted Date April 24, 2015
Last Update Posted Date April 28, 2015
Study Start Date May 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2015)
Right ventricular ejection fraction [ Time Frame: 6 months ]
3-dimensional acquisition of right ventricular ejection fraction using echocardiography
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 21, 2015)
  • Tricuspid annular plane systolic excursion [ Time Frame: 6 months ]
  • Right ventricular fractional area change [ Time Frame: 6 months ]
  • Right ventricular strain [ Time Frame: 6 months ]
  • Pulmonary artery acceleration time [ Time Frame: 6 months ]
  • Left ventricular ejection fraction [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
Official Title Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy
Brief Summary 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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery
Condition Chronic Thromboembolic Pulmonary Hypertension
Intervention Procedure: Pulmonary endarterectomy
Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.
Other Names:
  • Transoesophageal Echocardiography
  • Transthoracic Echocardiography
Study Groups/Cohorts Pulmonary Endarterectomy patients
Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital
Intervention: Procedure: Pulmonary endarterectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 21, 2015)
51
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02426203
Other Study ID Numbers P02016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Papworth Hospital NHS Foundation Trust
Study Sponsor Papworth Hospital NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Andrew J Roscoe, FRCA Papworth Hospital NHS Foundation Trust
PRS Account Papworth Hospital NHS Foundation Trust
Verification Date April 2015