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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Xavier Monnet, MD, PhD contact

00331 45 21 35 39

xavier.monnet@aphp.fr

France1 site, 1 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

    Recruiting

Other trials in France

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.

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 groups in NCT04864041
Study groupRoleWhat they receive
Patients hospitalised in ICU for vaso-occlusive crisisNot 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.

  1. Global longitudinal strain

    Measure of global longitudinal strain using speckle tracking echocardiography

    Measured: Day 0

  2. Global longitudinal strain

    Measure of global longitudinal strain using speckle tracking echocardiography

    Measured: Day 1

  3. Global longitudinal strain

    Measure of global longitudinal strain using speckle tracking echocardiography

    Measured: Day 2

Secondary outcomes (12)

  1. Troponine level

    Measured: Day 0

  2. Troponine level

    Measured: Day 1

  3. Troponine level

    Measured: Day 2

  4. Electrocardiogram QT interval

    Measured: Day 0

  5. Electrocardiogram QT interval

    Measured: Day 2

  6. Electrocardiogram ST elevation

    Measured: Day 0

  7. Electrocardiogram ST elevation

    Measured: Day 2

  8. Electrocardiogram negative T waves

    Measured: Day 0

  9. Electrocardiogram negative T waves

    Measured: Day 2

  10. Thoracic pain

    Numerical rating scale from 0 to 10 assessed by the patient

    Measured: Day 0

  11. Thoracic pain

    Numerical rating scale from 0 to 10 assessed by the patient

    Measured: Day 1

  12. 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.

  1. First posted28 Apr 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04864041.

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.

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