This study is intended to evaluate a new more in-depth and higher resolution cardiac MRI, MyoStrain®, to
transform the early detection of cardiac damage that can occur frequently as a result of cancer
chemotherapy. By detecting cardiac damage early, cardiologists can provide optimal cardio-protection
and allow continued use of life-saving cancer treatment for patients.
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PROactive evaluation of function to Avoid CardioToxicity
1. PROACTIVE EVALUATION OF FUNCTIONTO AVOID
CARDIOTOXICITY
PROACT
Principal Investigator:Daniel Lenihan,MD
Lead Site Coordinator:Kaitlin Moore
2. ABOUT THE STUDY
Prospective,multi-center,open label, randomized study
Other sites to include University ofTexas Southwestern,Yale, Franciscan St. Francis Health, and Duke. WUSTL to act as
lead coordinating site and will also be enrolling patients into the study.
Objectives:
To robustly quantify myocardial function in cancer patients scheduled to receive anti-cancer therapy
To determine the ability of Myostrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging
To determine the impact of Myostrain imaging on medical management of cardiotoxicity through early detection of at risk
patients.
Endpoints:
The primary efficacy endpoint is the sensitivity of detection of patients with myocardial dysfunction using Myostrain
compared to standard assessments of cardiac function: left ventricular ejection fraction (LVEF), as well as end-systolic
(LVESV) and end-diastolic (LVEDV) volumes.
10. INCLUSION/EXCLUSION CRITERIA AND RISK STRATIFICATION
Inclusion Criteria:
Participant in the SURVIVE Registry
Signed consent form for PROACT
Histological diagnosis of early or metastatic breast
cancer, lymphoma, or sarcoma (patients with
treated and clinically stable brain metastasis are
acceptable)
Scheduled to receive anti-cancer therapy (radiation
therapy is permitted)
Exclusion Criteria:
Contraindication to magnetic resonance imaging
(MRI)
Unable to comply with study investigations (in the
judgement of the investigator)
Life expectancy less than 1 year
Risk Stratification
High Risk Group
Baseline imaging demonstrates2 or more segments
measuring >-10% or 9 or more segments >-17%
Patients in this group will be randomized to either the
Myostrain Blinded,Standard of CareArm or the
Myostrain Guided,TreatmentArm
Patients will receive multiple follow-up MRIs
Low Risk Group
Baseline imaging demonstrates0 or 1 segment
measuring >10%
Patients in this group will not be randomized and will
only receive 1 follow-up MRI
11. Patients Enrolled in SURVIVE Registry
Signed Informed Consent for SURVIVE Registry
Signed PROACT Informed Consent Form
Inclusion Criteria
- Diagnosed with breast cancer,lymphoma,orsarcoma
- Scheduled to receive anti-cancertherapy with orwithout concomitant radiotherapy
If patient meets
inclusion criteria...
Baseline
MyoStrain® MRI
Testing
Risk Stratification
High Risk Group:Baseline MyoStrain® demonstrating 2 ormore segments measuring >-10%
Low Risk Group:Baseline MyoStrain® demonstrating0 or1 segments measuring >-10%
High Risk Group
Randomize
MyoStrain® Blinded
Standard of Care Arm
Standard of
Care Testing
MyoStrain®
Testing 1, 3, 6,
12, 24, 36 mo
Manage Patients
Based on Standard
of Care Only
MyoStrain® Guided
Treatment Arm
Standard of
Care Testing
MyoStrain®
Testing 1, 3, 6,
12, 24, 36 mo
Manage Patients Based on
Standard of Care and
MyoStrain® Results
Low Risk Group
MyoStrain®
Testing 6 mo
If patient doesn't meet
inclusion criteria...
Screen Failure
PROACT Schedule of Events
Baseline
1Month
(+1week)
3Month
(+1week)
6Month
(+1week)
12month
(+30days)
24month
(+30days)
36month
(+30days)
PROACT Informed Consent
Inclusion/Exclusion Criteria Confirmation
High Risk Group
MyoStrain® MRI Testing
Randomization
Patient Satisfaction Questionnaire
Low Risk Group
MyoStrain® MRI Testing
Patient Satisfaction Questionnaire
SCHEDULE OF EVENTS AND FLOW CHART
12. A LITTLE BIT ABOUT THE SURVIVE REGISTRY
The SURVIVE Registry is a multi-center registry.
It’s purpose to is to:
Identify the cancer therapeutics and the cancer
conditions in which cardiovascular dysfunction,
potentially as a result of cancer therapy, can recover
back to pre-chemotherapy levels or improve
substantially with effective cardiac treatment.
Describe the clinical tools that are most useful and
cost effective at promoting recovery of
cardiovascular dysfunction.
Improve the clinical detection treatment, and
outcomes of patients with cardiovascular
dysfunction that occurs during or as a result of
cancer therapy.
Inclusion Criteria:
All adult patients (> 18 years old) at time of consent
Previously treated or has planned treatment for any
type of cancer at any stage
Evidence of cardiovascular dysfunction or presence of
at least on cardiovascular risk factor documented by
history, physical, laboratory, or imaging methods
Exclusion Criteria:
Inability or refusal to provide informed consent (LARs
are permitted)
Patients must be enrolled in the SURVIVE Registry to participate in the PROACT study!