CardiotoxicityPhase 2PROACTNCT03862131
PROactive Evaluation of Function to Avoid CardioToxicity
A Phase 2 study testing MyoStrain® in people with Cardiotoxicity and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Breast Cancer, Lymphoma
- What is being tested?
- MyoStrain®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 14 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma, Leukemia, Myeloma
- Being tested
- MyoStrain®
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms, Lymphoma, Sarcoma, Leukemia, Neoplasms, Plasma Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoStrain®Device
Also called Cardiac MRI Imaging Software, Intramyocardial Strain
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
| Study group | Role | What they receive |
|---|---|---|
| MyoStrain® unblinded treatment arm | Experimental | * 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. Receives: Device: MyoStrain® |
| MyoStrain® blinded control arm | Active comparator | * 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. Receives: Device: MyoStrain® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: Through 36 months
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
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
Measured: Through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start13 Mar 2019
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Why it stopped: Insufficient funding/staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Myocardial Solutions
- Responsible party
- Sponsor
- Investigators
- Joshua Mitchell, M.D., MSCI, FACC, FICOS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862131
- Sponsor's protocol ID
- 201809177
- Acronym
- PROACT
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2019
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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)
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROactive Evaluation of Function to Avoid CardioToxicity
- ClinicalTrials.gov ID
- NCT03862131
- Acronym / sponsor ID
- PROACT / 201809177
- Conditions
- Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma, Leukemia, Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding/staff
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Myocardial Solutions
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyoStrain® unblinded treatment arm | Experimental | Device: MyoStrain®* 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. |
| MyoStrain® blinded control arm | Active comparator | Device: MyoStrain®* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoStrain®Also: Cardiac MRI Imaging Software, Intramyocardial StrainMyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images. | Device | MyoStrain® blinded control arm, MyoStrain® unblinded treatment arm |
Primary outcome
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.
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
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
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationDaniel 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)
- Results publicationJoshua 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)
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Mitchell, M.D., MSCI, FACC, FICOS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MyoStrain® in people with Cardiotoxicity and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862131, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.