PROactive Evaluation of Function to Avoid CardioToxicity (PROACT)

July 28, 2025 updated by: Washington University School of Medicine
This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of the PROACT study is to test the accuracy of MyoStrain® to detect cardiotoxicity in patients on high risk cancer therapy. After undergoing baseline MRI and meeting eligibility criteria, patients will be further randomized to an unblinded arm (MyoStrain® measured and available to the treatment team) and a blinded arm (MyoStrain® measured but not available to the treatment team). This randomization will aid in an exploratory aim of testing the feasibility of MyoStrain® to guide cardioprotective therapy in the unblinded vs blinded arms. However, as all patients will have MyoStrain® measured, all patients (both treatment arms) will be combined for testing the primary outcome measure.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant in the SURVIVE registry
  • Signed informed consent form for PROACT
  • Histological diagnosis of any cancer type (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 judgment of the investigator)
  • Life expectancy less than 1 year
  • Note: If a patient develops a temporary contraindication (e.g. temporary tissue expanders in breast cancer patients) after the baseline MRI, follow up MRIs will be discontinued for safety for the duration in which the patient has the contraindication. However, once the patient is no longer contraindicated to receiving MRIs, the study schedule may resume with their next scheduled MRI time point from the date of enrollment. Therefore, some time points may be skipped during the patient's enrollment in the study.

Also, if a patient needs a repeat MRI at any time point for any reason (i.e. panic attack during the MRI causing them to not be able to continue, unreadable images, etc.), we may repeat the MRI as long as the patient is willing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyoStrain® unblinded treatment arm
  • After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring >-10% or 9 or more segments >-17% for entrance into the study as the Higher Risk Group
  • The unblinded treatment arm will enhance patient management by augmenting standard of care with serial MyoStrain® monitoring of the impact of cancer therapy on myocardial function.
  • Higher Risk unblinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.
  • In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.
Device: MyoStrain®
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
Other Names:
  • Cardiac MRI Imaging Software
  • Intramyocardial Strain
Active Comparator: MyoStrain® blinded control arm
  • After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring >-10% or 9 or more segments >-17% for entrance into the study as the Higher Risk group
  • The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care
  • Higher Risk blinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.
  • In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.
Device: MyoStrain®
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
Other Names:
  • Cardiac MRI Imaging Software
  • Intramyocardial Strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROC AUC of MyoStrain® Compared to Standard CMR Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Time Frame: Through 36 months

The area under the curve refers to the area under the curve of Receiver operating characteristic curves (ROC AUC) to evaluate the accuracy of MyoStrain® to detect cardiotoxicity compared to Cardiovascular Magnetic Resonance (CMR) Imaging standard measurements.

  • Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity.
  • Clinical cardiotoxicity was defined as an absolute change in LVEF > 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL.
  • In patients with LVEF < 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF > 10% or a HF hospitalization.
  • Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP >199 pg/mL.
Through 36 months
Sensitivity of MyoStrain® Compared to CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Time Frame: Through 36 months

Sensitivity is defined as the number of true positives divided by the number of true positives + number of false negatives.

  • Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity.
  • Clinical cardiotoxicity was defined as an absolute change in LVEF > 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL.
  • In patients with LVEF < 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF > 10% or a HF hospitalization.
  • Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP >199 pg/mL
Through 36 months
Specificity of MyoStrain® and CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Time Frame: Through 36 months

Specificity is defined as the number of true negatives divided by the number of true negatives + number of false positives.

  • Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity.
  • Clinical cardiotoxicity was defined as an absolute change in LVEF > 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL.
  • In patients with LVEF < 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF > 10% or a HF hospitalization.
  • Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP > 199 pg/mL
Through 36 months
Accuracy of MyoStrain® and CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Time Frame: Through 36 months

Accuracy is defined as (true positives + true negatives) divided by the total number of cases

  • Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity.
  • Clinical cardiotoxicity was defined as an absolute change in LVEF > 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL.
  • In patients with LVEF < 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF > 10% or a HF hospitalization.
  • Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP >199 pg/mL.
Through 36 months
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
Time Frame: Through 36 months

Myocardial dysfunction is the occurrence of either clinical or subclinical cardiotoxicity.

  • Clinical cardiotoxicity was defined as an absolute change in LVEF >10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL
  • In patients with LVEF <53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF >10% or a HF hospitalization
  • Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP >199 pg/mL
Through 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Myocardial Solutions

Investigators

  • Principal Investigator: Joshua Mitchell, M.D., MSCI, FACC, FICOS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Daniel J. Lenihan, Gregory M. Lanza, Pamela K. Woodard, Joshua Mitchell, SUPERIOR DETECTION OF CARDIOTOXICITY USING CARDIAC MRI MYOSTRAIN DURING CANCER CHEMOTHERAPY, Journal of the American College of Cardiology, Volume 83, Issue 13, Supplement, 2024, Page 2350, ISSN 0735-1097, https://doi.org/10.1016/S0735-1097(24)04340-7. (https://www.sciencedirect.com/science/article/pii/S0735109724043407)
  • Joshua Mitchell, Syed Z. Qamer, Gregory M. Lanza, Pamela K. Woodard, JAMES WHAYNE, Daniel J. Lenihan, MYOCARDIAL STRAIN GUIDED CARDIOPROTECTION DURING CHEMOTHERAPY WITH CARDIAC MRI IMPROVES CARDIAC HEALTH, Journal of the American College of Cardiology, Volume 83, Issue 13, Supplement, 2024, Page 2673, ISSN 0735-1097, https://doi.org/10.1016/S0735-1097(24)04663-1. (https://www.sciencedirect.com/science/article/pii/S0735109724046631)

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Actual)

June 14, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201809177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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