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PROACTIVE EVALUATION OF FUNCTIONTO AVOID
CARDIOTOXICITY
PROACT
Principal Investigator:Daniel Lenihan,MD
Lead Site Coordinator:Kaitlin Moore
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.
PILOT DATA
PILOT DATA
PILOT DATA
PILOT DATA
PILOT DATA
PILOT DATA
PILOT DATA
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
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
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!
QUESTIONS?

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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!