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Cardiac MRI for Heart Issues After Sepsis in Pediatric Cancer Patients
N/A
Recruiting
Led By Anthony Merlocco, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 9 and 25 years of age at time of study enrollment
Be younger than 65 years old
Must not have
Participant has been diagnosed with clinically significant left ventricular dysfunction (EF < 55%) prior to the onset of sepsis
Estimated glomerular filtration rate < 45 ml/minute/1.73m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 10 days after onset of sepsis
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to identify heart issues in kids with cancer after sepsis, and use MRI tests to guide treatment decisions.
Who is the study for?
This trial is for pediatric cancer patients at St. Jude, aged 9-25, who have recently suffered from severe sepsis. They must be stable enough post-sepsis to undergo a cardiac MRI without anesthesia and not have significant heart dysfunction or conditions that make MRI unsafe.
What is being tested?
The study tests the use of cardiac MRI to detect heart issues in children with cancer after sepsis. It checks if MRIs can be done safely soon after sepsis and how often these scans show heart inflammation or dysfunction within 10 days of a severe sepsis episode.
What are the potential side effects?
Cardiac MRI is generally safe but may include discomfort due to lying still during the scan, loud noises from the machine, and potential reactions to contrast agents used for clearer images if applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 9 and 25 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with a weak heart (EF < 55%) before getting a severe infection.
Select...
My kidney function is reduced, with an eGFR below 45.
Select...
I have had a bone marrow transplant or CAR-T cell therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 10 days of presentation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 10 days of presentation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of cardiac MRI in pediatric oncology patients with sepsis
Frequency of subacute sepsis-associated cardiac disease
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac MRI after sepsisExperimental Treatment1 Intervention
Participants who meet the eligibility criteria of severe sepsis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac MRI
2017
Completed Phase 4
~3210
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,461 Total Patients Enrolled
Anthony Merlocco, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a weak heart (EF < 55%) before getting a severe infection.My kidney function is reduced, with an eGFR below 45.You have been diagnosed with severe sepsis based on specific medical guidelines.I am between 9 and 25 years old.I have had a bone marrow transplant or CAR-T cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac MRI after sepsis
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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