Right VentricleSPECKLETHONCT05060302
Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery
A study testing transthoracic echocardiography (TTE) in people with Right Ventricle and Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricle, Thoracic Surgery
- What is being tested?
- transthoracic echocardiography (TTE)
- How many people
- 191 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study
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.
- Conditions
- Right Ventricle, Thoracic Surgery
- Being tested
- transthoracic echocardiography (TTE)
- Keywords
- Right ventricle, speckle tracking, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiography (TTE)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 30
Secondary outcomes (10)
Variation of RV systolic function from baseline in patients with MACE
Measured: at day 1
Variation of RV systolic function from baseline in patients without MACE
Measured: at day 1
Variation of RV systolic function from baseline in patients with MACE
Measured: at day 2
Variation of RV systolic function from baseline in patients without MACE
Measured: at day 2
Variation of RV systolic function from baseline in patients with MACE
Measured: at day 15
Variation of RV systolic function from baseline in patients without MACE
Measured: at day 15
Variation of RV systolic function from baseline in patients with MACE
Measured: within day 30
Variation of RV systolic function from baseline in patients without MACE
Measured: within day 30
Assessment of RV systolic function preoperatively
Measured: at day 30
occurrence of a postoperative complication
Measured: at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start13 Sep 2021
- Primary completion8 Nov 2023
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right VentricleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060302
- Sponsor's protocol ID
- PI2021_843_0030
- Acronym
- SPECKLETHO
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT05060302
- Acronym / sponsor ID
- SPECKLETHO / PI2021_843_0030
- Conditions
- Right Ventricle, Thoracic Surgery
- Keywords
- Right ventricle, speckle tracking, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiography (TTE)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. | Other | – |
Primary outcome
occurrence of a major cardiovascular event (MACE)
Time frame: day 30
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.
10 secondary outcomes
Variation of RV systolic function from baseline in patients with MACE
Time frame: at day 1
Variation of RV systolic function from baseline in patients without MACE
Time frame: at day 1
Variation of RV systolic function from baseline in patients with MACE
Time frame: at day 2
Variation of RV systolic function from baseline in patients without MACE
Time frame: at day 2
Variation of RV systolic function from baseline in patients with MACE
Time frame: at day 15
Variation of RV systolic function from baseline in patients without MACE
Time frame: at day 15
Variation of RV systolic function from baseline in patients with MACE
Time frame: within day 30
Variation of RV systolic function from baseline in patients without MACE
Time frame: within day 30
Assessment of RV systolic function preoperatively
Time frame: at day 30
occurrence of a postoperative complication
Time frame: at day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Right Ventricle
Not yet recruiting
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Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
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Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
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Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transthoracic echocardiography (TTE) in people with Right Ventricle and Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of a major cardiovascular event (MACE) (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.