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MyoStrain® for Cardiotoxicity (PROACT Trial)

Phase 2

Waitlist Available

Led By Daniel J Lenihan, M.D., FACC

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 36 months

Awards & highlights

PROACT Trial Summary

This trial will help determine if using a special software to analyze MRI scans can help doctors detect and manage heart problems caused by cancer treatments.

Who is the study for?

This trial is for people in the SURVIVE registry with any cancer type, including those with stable brain metastasis. They must be set to receive anti-cancer therapy and have signed a consent form. It's not specified who can't join because the exclusion criteria are missing.Check my eligibility

What is being tested?

The study tests MyoStrain®, an advanced cardiac MRI technology, to see if it can detect and manage heart damage early in patients undergoing cancer treatment.See study design

What are the potential side effects?

Since MyoStrain® involves non-invasive imaging without drugs or radiation, significant side effects aren't expected. However, typical MRI-related discomforts may occur.

PROACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ability of MyoStrain testing to detect risk of developing cardiotoxicity compared to standard cardiac imaging as measured by left ventricular ejection fraction

Ability of MyoStrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging as measured by left ventricular ejection fraction

Impact of MyoStrain imaging on medical management of cardiotoxicity through early detection of at risk patients compared to standard cardiac imaging as measured by left ventricular ejection fraction

+4 more

PROACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyoStrain® unblinded treatment armExperimental Treatment1 Intervention

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.

Group II: MyoStrain® blinded control armActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,660 Total Patients Enrolled

1 Trials studying Cardiotoxicity

73 Patients Enrolled for Cardiotoxicity

Myocardial SolutionsIndustry Sponsor

2 Previous Clinical Trials

76 Total Patients Enrolled

1 Trials studying Cardiotoxicity

63 Patients Enrolled for Cardiotoxicity

Daniel J Lenihan, M.D., FACCPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being enrolled in this experiment currently?

"According to the latest information available on clinicaltrials.gov, this study is not looking for new patients at this time. This particular trial was posted on March 13th, 2019 and updated on June 9th, 2022. Although this specific study has closed recruitment, there are 5186 other studies that are still looking for participants."

Answered by AI

What are the risks associated with MyoStrain treatment?

"Although Phase 2 trials are not as reliable as Phase 3 ones, there is some evidence to support MyoStrain's® safety. However, its efficacy has yet to be proven in clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROactive Evaluation of Function to Avoid CardioToxicity

2019. "PROactive Evaluation of Function to Avoid CardioToxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03862131.

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