Sickle Cell DiseaseNCT04864041
Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis
An observational study of Sickle Cell Disease, run by Bicetre Hospital at 1 site in France.
Trial summary
Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Evaluation of global longitudinal strain using routinely recorded echocardiography images
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Dec 2023
- Phase
- Observational
- 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
Study population: Patient with vaso occlusive crisis hospitalised in an intensive care unit.
Who may be able to join
- Hospitalisation in an intensive care unit for vaso-occlusive crisis
Who cannot join
- Pregnancy
- Individuals under guardianship
- Unsufficient echogenicity
- Thoracic pain prohibiting echocardiography assessment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Medical Intensive Care Unit
Le Kremlin-Bicêtre
Xavier Monnet, MD, PhD, 00331 45 21 35 39, xavier.monnet@aphp.fr
Xavier Monnet, MD, PhD
About this study
Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.
- Conditions
- Sickle Cell Disease
- Being tested
- Evaluation of global longitudinal strain using routinely recorded echocardiography images
- Keywords
- ICU Intensive Care Units, Transthoracic Echocardiography, Left Ventricular Function
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of global longitudinal strain using routinely recorded echocardiography imagesOther
There are no particular intervention performed in patients in this study, because echocardiography is part of the standard of care of patients hospitalised in the ICU for vaso occlusive crisis.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalised in ICU for vaso-occlusive crisis | Not described Receives: Other: Evaluation of global longitudinal strain using routinely recorded echocardiography images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain
Measure of global longitudinal strain using speckle tracking echocardiography
Measured: Day 0
Global longitudinal strain
Measure of global longitudinal strain using speckle tracking echocardiography
Measured: Day 1
Global longitudinal strain
Measure of global longitudinal strain using speckle tracking echocardiography
Measured: Day 2
Secondary outcomes (12)
Troponine level
Measured: Day 0
Troponine level
Measured: Day 1
Troponine level
Measured: Day 2
Electrocardiogram QT interval
Measured: Day 0
Electrocardiogram QT interval
Measured: Day 2
Electrocardiogram ST elevation
Measured: Day 0
Electrocardiogram ST elevation
Measured: Day 2
Electrocardiogram negative T waves
Measured: Day 0
Electrocardiogram negative T waves
Measured: Day 2
Thoracic pain
Numerical rating scale from 0 to 10 assessed by the patient
Measured: Day 0
Thoracic pain
Numerical rating scale from 0 to 10 assessed by the patient
Measured: Day 1
Thoracic pain
Numerical rating scale from 0 to 10 assessed by the patient
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Monnet, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864041
- Sponsor's protocol ID
- 2021-A00623-38
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 29 Apr 2021
- 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 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis
- ClinicalTrials.gov ID
- NCT04864041
- Acronym / sponsor ID
- 2021-A00623-38
- Conditions
- Sickle Cell Disease
- Keywords
- ICU Intensive Care Units, Transthoracic Echocardiography, Left Ventricular Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Apr 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.
Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalised in ICU for vaso-occlusive crisis | – | Other: Evaluation of global longitudinal strain using routinely recorded echocardiography images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with vaso occlusive crisis hospitalised in an intensive care unit.
Key inclusion criteria (1 listed)
- Hospitalisation in an intensive care unit for vaso-occlusive crisis
Key exclusion criteria (4 listed)
- Pregnancy
- Individuals under guardianship
- Unsufficient echogenicity
- Thoracic pain prohibiting echocardiography assessment
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 |
|---|---|---|
| Evaluation of global longitudinal strain using routinely recorded echocardiography imagesThere are no particular intervention performed in patients in this study, because echocardiography is part of the standard of care of patients hospitalised in the ICU for vaso occlusive crisis. | Other | Patients hospitalised in ICU for vaso-occlusive crisis |
Primary outcome
Global longitudinal strain
Time frame: Day 0
Measure of global longitudinal strain using speckle tracking echocardiography
Global longitudinal strain
Time frame: Day 1
Measure of global longitudinal strain using speckle tracking echocardiography
Global longitudinal strain
Time frame: Day 2
Measure of global longitudinal strain using speckle tracking echocardiography
12 secondary outcomes
Troponine level
Time frame: Day 0
Troponine level
Time frame: Day 1
Troponine level
Time frame: Day 2
Electrocardiogram QT interval
Time frame: Day 0
Electrocardiogram QT interval
Time frame: Day 2
Electrocardiogram ST elevation
Time frame: Day 0
Electrocardiogram ST elevation
Time frame: Day 2
Electrocardiogram negative T waves
Time frame: Day 0
Electrocardiogram negative T waves
Time frame: Day 2
Thoracic pain
Time frame: Day 0
Thoracic pain
Time frame: Day 1
Thoracic pain
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Bicetre Hospital 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Monnet, MD, PhD (00331 45 21 35 39, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global longitudinal strain (time frame: Day 0). The study lists 3 primary outcomes in all. 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 29 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.