Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309862
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-02-12
Brief Title:
Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients undergoing dual treatment with Immune checkpoint inhibitors ICI for various cancers eg melanoma are at increased risk of developing myocarditis and cardiomyopathy Currently only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available Cardiac MRI CMR is the reference standard for non-invasive myocardial volumesfunction analysis and uniquely characterizes myocardial tissue Therefore it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes
Detailed Description:
As patients going through cancer therapy live longer they are at a higher risk of developing cardiovascular disease Hence the evolving field of Cardio-Oncology has garnered much attention and importance In recent years immune checkpoint inhibitors ICI have become an essential component of cancer therapy significantly improving patient outcomes that were previously considered palliative eg metastatic melanoma renal cell or lung cancer and these therapies have improved survival
With ICI therapy and especially with combination therapy patients may develop severe ICI-related adverse events eg myocarditis 1-5 which is fatal in 30-50 of the patients Another more significant subgroup of patients will develop non-inflammatory cardiomyopathy or other major cardiac events like cardiovascular death cardiac arrest etc There is also evidence that during ICI treatment atherosclerotic disease may progress Identifying patients at risk for both remains a major challenge and is a knowledge gap in Cardio-Oncology
Cardiovascular magnetic resonance CMR is a unique highly reproducible multiparametric method for non-invasive myocardial tissue characterization for diagnosing myocardial inflammation Biomarkers like quantitative cardiac relaxometry T1T2-Mapping with extracellular volume fraction ECV delayed gadolinium enhancement LGE or myocardial strain show insights into myocardial tissue composition These biomarkers have the potential to identify early myocardial changes before the risk of clinical myocarditis or non-inflammatory cardiomyopathy occurs and may therefore help identify early myocardial tissue changes during ICI treatment and help identify patients at risk early on Also CMR can assess the aorta with high temporal and spatial resolution to identify atherosclerotic changes
Only a few retrospective studies and case reports with small numbers of patients have investigated ICI-related cardiac events during treatment Evidence shows that many patients present with heart failure 80 but troponin is only elevated in 45 This indicates that ICI-associated left ventricular LV dysfunction may exist without troponin elevation Other data suggests that the ICI-associated myocardial tissue inflammation pattern might differ from viral myocarditis The myocardial T1T2 relaxation times may be elevated during ICI-associated myocardial inflammation There is also evidence that strain changes are associated with adverse events within 30 days of treatment However all these studies demonstrate CMR findings when patients have already developed LV dysfunction or myocarditis The proposed project would be the first prospective study to get deeper insights into serial systematic ICI-associated myocardial tissue changes during treatment and their correlation with serum biomarkers and clinical symptoms
With ICI therapy and especially with combination therapy patients may develop severe ICI-related adverse events eg myocarditis 1-5 which is fatal in 30-50 of the patients Another more significant subgroup of patients will develop non-inflammatory cardiomyopathy or other major cardiac events like cardiovascular death cardiac arrest etc There is also evidence that during ICI treatment atherosclerotic disease may progress Identifying patients at risk for both remains a major challenge and is a knowledge gap in Cardio-Oncology
Cardiovascular magnetic resonance CMR is a unique highly reproducible multiparametric method for non-invasive myocardial tissue characterization for diagnosing myocardial inflammation Biomarkers like quantitative cardiac relaxometry T1T2-Mapping with extracellular volume fraction ECV delayed gadolinium enhancement LGE or myocardial strain show insights into myocardial tissue composition These biomarkers have the potential to identify early myocardial changes before the risk of clinical myocarditis or non-inflammatory cardiomyopathy occurs and may therefore help identify early myocardial tissue changes during ICI treatment and help identify patients at risk early on Also CMR can assess the aorta with high temporal and spatial resolution to identify atherosclerotic changes
Only a few retrospective studies and case reports with small numbers of patients have investigated ICI-related cardiac events during treatment Evidence shows that many patients present with heart failure 80 but troponin is only elevated in 45 This indicates that ICI-associated left ventricular LV dysfunction may exist without troponin elevation Other data suggests that the ICI-associated myocardial tissue inflammation pattern might differ from viral myocarditis The myocardial T1T2 relaxation times may be elevated during ICI-associated myocardial inflammation There is also evidence that strain changes are associated with adverse events within 30 days of treatment However all these studies demonstrate CMR findings when patients have already developed LV dysfunction or myocarditis The proposed project would be the first prospective study to get deeper insights into serial systematic ICI-associated myocardial tissue changes during treatment and their correlation with serum biomarkers and clinical symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None