MyocarditisIMMUNOIMAGINGNCT05086146
Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis
An observational study of Myocarditis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2021to Mar 2024
- 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: all patients with suspected myocarditis on ICIs.
Who may be able to join
- All patients affiliated to the French social security system will be eligible, after signing a consent form, and presenting the following criteria
- Introduction within the last 3 months of at least one of the following ICIs: nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, ipilimumab, tremelimumab, durvalumab.
- Suspicion of myocarditis defined by the presence of at least one of the following criteria adapted from the European Society of Cardiology guidelines:
- Symptomatic patients (chest pain, dyspnea, palpitations, syncope/lipothymia) within 7 days of ICI administration
- New ECG abnormality (ST-segment elevation, ST-segment undershift, arrhythmia, conductive disturbances, T-wave inversion)
- Elevation of troponin above the 99th percentile of the laboratory reference value or, if troponin is already elevated before treatment, an increase of more than 30% of the baseline value
Show all 9Show fewer
- Recent LVEF decline or recent LV contraction abnormality on a TTE
- Patient has given no objection
- Translated with www.DeepL.com/Translator (free version)
Who cannot join
- Age <18 years
- Major under guardianship or curatorship
- Pregnant or breastfeeding women
- Patient not covered by a social security plan
- Hemodynamic or rhythmic instability
- Estimation of glomerular filtration rate by the MDRD formula <30ml/min/1.73m2
- Implantable equipment that does not allow for cMRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
assistance publique hôpitaux de Marseille
Marseille, 13354
deharo francois, (0)4 91 96 86 83, francois.deharo@ap-hm.fr
About this study
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.
Read the detailed description
Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to the investigators gold standard protocol. After 48 hours, the participants will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.
- Conditions
- Myocarditis
- Medical subject headings
- Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of the composite end point
including cardiovascular death, acute heart failure, cardiogenic shock, cardiac arrest, sustained ventricular tachycardia, ventricular fibrillation, 2nd-degree (except Mobitz 1) or 3rd-degree atrioventricular block.
Measured: 6-month
Secondary outcomes (1)
Cumulative incidence rate of all-cause death
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start10 Aug 2021
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086146
- Sponsor's protocol ID
- 2020-63
- Other IDs
- 2020-A03384-35
- Acronym
- IMMUNOIMAGING
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis
- ClinicalTrials.gov ID
- NCT05086146
- Acronym / sponsor ID
- IMMUNOIMAGING / 2020-63
- Conditions
- Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 20 Oct 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.
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.
Detailed description
Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to the investigators gold standard protocol. After 48 hours, the participants will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with suspected myocarditis on ICIs.
Key inclusion criteria (9 listed)
- All patients affiliated to the French social security system will be eligible, after signing a consent form, and presenting the following criteria
- Introduction within the last 3 months of at least one of the following ICIs: nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, ipilimumab, tremelimumab, durvalumab.
- Suspicion of myocarditis defined by the presence of at least one of the following criteria adapted from the European Society of Cardiology guidelines:
- Patient has given no objection
- Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria (7 listed)
- Age <18 years
- Major under guardianship or curatorship
- Pregnant or breastfeeding women
- Patient not covered by a social security plan
- Hemodynamic or rhythmic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence rate of the composite end point
Time frame: 6-month
including cardiovascular death, acute heart failure, cardiogenic shock, cardiac arrest, sustained ventricular tachycardia, ventricular fibrillation, 2nd-degree (except Mobitz 1) or 3rd-degree atrioventricular block.
1 secondary outcome
Cumulative incidence rate of all-cause death
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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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.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
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 Myocarditis, run by Assistance Publique Hopitaux De Marseille 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 9 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: status not confirmed, as of the sponsor's last update on 20 Oct 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 DEHARO PIERRE ((0)4 91 96 86 83 ext. +33, pierre.deharo@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence rate of the composite end point (time frame: 6-month). 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 20 Oct 2021.