Cardiac MRI for Heart Issues After Sepsis in Pediatric Cancer Patients

Recruiting in Palo Alto (17 mi)

Overseen by Anthony Merlocco, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Left ventricular dysfunction, Pregnancy, Renal dysfunction, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction. Primary Objectives: (Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer. CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness. (Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Cardiac MRI for heart issues after sepsis in pediatric cancer patients?

Cardiac MRI is a valuable tool in cardio-oncology for diagnosing and managing heart problems related to cancer and its treatments. It is particularly effective in detecting subtle changes in heart function and tissue, which can help identify heart damage early and guide treatment decisions. ^{1 2 3 4 5}

Is cardiac MRI safe for humans?

Cardiac MRI is generally considered safe, with studies showing it is a useful tool in diagnosing heart issues in various conditions, including cancer and congenital heart disease. However, there can be some risks, such as adverse events when using contrast agents, but these are typically rare. ^{3 6 7 8 9}

How is cardiac MRI used as a treatment for heart issues after sepsis in pediatric cancer patients different from other treatments?

Cardiac MRI is unique because it is a noninvasive imaging technique that provides detailed information about heart structure and function, which is particularly useful for detecting subtle changes in heart tissue and function related to cancer treatments. Unlike other treatments that may focus on symptoms or direct interventions, cardiac MRI helps in diagnosing and managing heart complications by offering precise and comprehensive heart assessments. ^{2 3 4 7 10}

Research Team

Anthony Merlocco, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with severe sepsis based on specific medical guidelines.

I am between 9 and 25 years old.

Currently receiving care for cancer at St. Jude

Exclusion 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.

Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Participant is pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Evaluate the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer

Up to 2 years

Initial CMR within 10 days of sepsis presentation

Completion Phase

Evaluate for abnormalities on CMR in approximately 20 participants

18-24 months

CMR evaluation within 10 days of sepsis presentation

Follow-up

Participants are monitored for cardiac abnormalities and recovery post-CMR

4 weeks

Treatment Details

Interventions

• Cardiac MRI (Procedure)

Trial Overview 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.

Participant Groups

Group I: Cardiac MRI after sepsis Experimental Treatment 1 Intervention

Participants who meet the eligibility criteria of severe sepsis.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Dr. James R. Downing

St. Jude Children's Research Hospital

Chief Executive Officer since 2014

MD from University of Michigan Medical School

Dr. Ellis J. Neufeld

St. Jude Children's Research Hospital

Chief Medical Officer since 2017

MD, PhD from Harvard Medical School

Findings from Research

Cardiac magnetic resonance (CMR) imaging has become essential in evaluating pediatric heart disease, providing detailed insights that enhance the assessment of both congenital and acquired conditions.

CMR can often replace invasive procedures like angiographic catheterization, making it a safer option for patients, while also complementing traditional echocardiography for more comprehensive cardiac evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in pediatric cardiovascular magnetic resonance imaging. Ntsinjana, HN., Tann, O., Taylor, AM.[2022]

Cardiac MRI is increasingly recognized for its role in evaluating heart problems in cancer patients, helping to identify cardiac abnormalities and dysfunction related to cancer treatments.

Current guidelines now recommend the use of cardiac MRI as a noninvasive tool in cancer management, highlighting its importance in both diagnosing and managing cardiovascular complications associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI in cardio-oncology: A review of cardiac complications in oncologic care. Jeong, D., Gladish, G., Chitiboi, T., et al.[2020]

Cardiac magnetic resonance (CMR) imaging is highly accurate and reproducible, making it a valuable tool for diagnosing and screening for cardiotoxicity and other cardiac diseases in cancer patients.

CMR's ability to detect subtle changes in heart function and tissue composition enhances our understanding of cardiotoxicity, highlighting its growing importance in both clinical practice and research within cardio-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular MRI in Cardio-Oncology. Bottinor, W., Trankle, CR., Hundley, WG.[2022]

Automated segmentation of left ventricular parameters in pediatric cardiac MRI was successful in 93.3% of cases, indicating its feasibility for assessing heart function in children, particularly those with suspected myocarditis.

Manual adjustments to the automated segmentation improved the accuracy of certain measurements, such as ejection fraction and myocardial mass, providing clinically acceptable results for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric cardiac MRI: automated left-ventricular volumes and function analysis and effects of manual adjustments. Hammon, M., Janka, R., Dankerl, P., et al.[2018]

Cancer therapies can lead to both short-term and long-term cardiovascular issues, making it crucial to identify patients at risk for cardiotoxicity early on.

Cardiovascular magnetic resonance (MR) imaging is a promising tool in cardio-oncology, offering a comprehensive evaluation of cardiac structures beyond just assessing left-ventricular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular MR imaging in cardio-oncology. Tamene, AM., Masri, C., Konety, SH.[2014]

Cardiac MRI is safe for critically ill infants with congenital heart disease, showing low risk and minimal hemodynamic changes during the procedure, as evidenced by a study of 20 patients in the pediatric cardiac intensive care unit.

The imaging provided crucial information that led to surgical or catheter interventions in 70% of the cases, highlighting its clinical utility in guiding management decisions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? Sarikouch, S., Schaeffler, R., Körperich, H., et al.[2021]

Cardiac MRI is a powerful tool for diagnosing and managing cardiovascular issues in cancer patients, effectively distinguishing between benign and malignant cardiac tumors and assessing the impact of cancer treatments on heart health.

The technique can detect both early and long-term cardiotoxic effects of cancer therapies using advanced imaging sequences, making it essential for integrated cancer care and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Magnetic Resonance Imaging in Oncology. Jeong, D., Patel, A., Francois, CJ., et al.[2018]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

Patients undergoing potentially cardiotoxic cancer treatments are at risk for various heart issues, including reduced left ventricular mass and impaired heart function.

Cardiovascular magnetic resonance imaging is a valuable tool for evaluating heart structure and function in these patients, aiding in the diagnosis and management of heart disease related to cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in the Oncology Patient. Jordan, JH., Todd, RM., Vasu, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Trends in pediatric cardiovascular magnetic resonance imaging. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

MRI in cardio-oncology: A review of cardiac complications in oncologic care. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular MRI in Cardio-Oncology. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pediatric cardiac MRI: automated left-ventricular volumes and function analysis and effects of manual adjustments. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular MR imaging in cardio-oncology. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiac Magnetic Resonance Imaging in Oncology. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in the Oncology Patient. [2023]