Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery (SPECKLETHO)
Primary Purpose
Right Ventricle, Thoracic Surgery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transthoracic echocardiography (TTE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Right Ventricle focused on measuring Right ventricle, speckle tracking, thoracic surgery
Eligibility Criteria
Inclusion Criteria:
- Adult patient (>18 years)
- Patient hospitalized at the Amiens University Hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection).
- Surgery by thoracotomy or video-assisted thoracic surgery
- Information of the patient and collection of his non-opposition
Exclusion Criteria:
- Patient with poor echogenicity on TTE not allowing evaluation of 2D-STE or conventional parameters of the RV.
- Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE
- Patient under mechanical ventilation
- Patient under extracorporeal membrane oxygenation
- Patients under guardianship or legal protection
- Patients whose clinical condition does not allow for their non-opposition
- Pregnant women
Sites / Locations
- CHU Amiens PicardieRecruiting
Outcomes
Primary Outcome Measures
occurrence of a major cardiovascular event (MACE)
MACE is a composite criteria. MACES criteria is defined as the occurrence of at least one of the following events: A cardiovascular death or a documented supraventricular tachycardia (atrial fibrillation and/or flutter) of duration > 30 seconds or, an acute myocardial infarction or, an hospitalization for a right ventricular failure or, an hospitalization for a left ventricular failure.
Secondary Outcome Measures
Variation of RV systolic function from baseline in patients with MACE
Variation of RV systolic function from baseline in patients without MACE
Variation of RV systolic function from baseline in patients with MACE
Variation of RV systolic function from baseline in patients without MACE
Variation of RV systolic function from baseline in patients with MACE
Variation of RV systolic function from baseline in patients without MACE
Variation of RV systolic function from baseline in patients with MACE
Variation of RV systolic function from baseline in patients without MACE
Assessment of RV systolic function preoperatively
occurrence of a postoperative complication
Full Information
NCT ID
NCT05060302
First Posted
September 15, 2021
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05060302
Brief Title
Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery
Acronym
SPECKLETHO
Official Title
Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.
This project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricle, Thoracic Surgery
Keywords
Right ventricle, speckle tracking, thoracic surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
transthoracic echocardiography (TTE)
Intervention Description
the included patients have a TTE preoperatively in order to evaluate the RV systolic function. TTE will also be done at day 2 and day-15 during the follow-up surgical consultation.
Primary Outcome Measure Information:
Title
occurrence of a major cardiovascular event (MACE)
Description
MACE is a composite criteria. MACES criteria is defined as the occurrence of at least one of the following events: A cardiovascular death or a documented supraventricular tachycardia (atrial fibrillation and/or flutter) of duration > 30 seconds or, an acute myocardial infarction or, an hospitalization for a right ventricular failure or, an hospitalization for a left ventricular failure.
Time Frame
day 30
Secondary Outcome Measure Information:
Title
Variation of RV systolic function from baseline in patients with MACE
Time Frame
at day 1
Title
Variation of RV systolic function from baseline in patients without MACE
Time Frame
at day 1
Title
Variation of RV systolic function from baseline in patients with MACE
Time Frame
at day 2
Title
Variation of RV systolic function from baseline in patients without MACE
Time Frame
at day 2
Title
Variation of RV systolic function from baseline in patients with MACE
Time Frame
at day 15
Title
Variation of RV systolic function from baseline in patients without MACE
Time Frame
at day 15
Title
Variation of RV systolic function from baseline in patients with MACE
Time Frame
within day 30
Title
Variation of RV systolic function from baseline in patients without MACE
Time Frame
within day 30
Title
Assessment of RV systolic function preoperatively
Time Frame
at day 30
Title
occurrence of a postoperative complication
Time Frame
at day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (>18 years)
Patient hospitalized at the Amiens University Hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection).
Surgery by thoracotomy or video-assisted thoracic surgery
Information of the patient and collection of his non-opposition
Exclusion Criteria:
Patient with poor echogenicity on TTE not allowing evaluation of 2D-STE or conventional parameters of the RV.
Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE
Patient under mechanical ventilation
Patient under extracorporeal membrane oxygenation
Patients under guardianship or legal protection
Patients whose clinical condition does not allow for their non-opposition
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Beyls, MD
Phone
0322087866
Email
Beyls.Christophe@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Beyls, MD
Phone
0322087866
Email
Beyls.Christophe@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery
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