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Completed

NCT Number: NCT03543228

MyoStrain CMR for the Detection of Cardiotoxicity

The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Toxicity Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Sprains and Strains Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marien Krankenhaus GmbH

Hamburg, 22087, Germany

About this study

The study is a prospective, observational, single center, observational clinical study that will enroll up to 50 patients undergoing chemotherapy and/or targeted therapy with or without concomitant radiotherapy for the treatment of breast cancer or lymphoma. Enrolled subjects will be evaluated with the MyoStrain SENC CMR Imaging System that measures myocardial strain during standard Cardiac Magnetic Resonance imaging at baseline through 6 month follow-up.

The MyoStrain SENC CMR Imaging System has been approved with an EC Certificate according to Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 (CE 657862) in respect of: Design, development and manufacture of software for the quantification of cardiac MRI images. MyoStrain measures the contraction of heart muscle in one heartbeat per image plane. With 6 image planes (3 short axis & 3 long axis), a complete measure of the health of the myocardium, both regionally and globally, can be obtained within a minute without requiring contrast injection or a breath-hold.

Heart health will be monitored throughout cancer therapy to quantify the toxic effects of chemotherapy with or without a reduction in traditional measures such as ejection fraction, and the ability to reverse observed cardiotoxicity with standard heart failure therapy.

The goal of the study is to determine the ability to detect subclinical cardiotoxicity before extensive damage causes the reduction in traditional measures, which are currently used to categorize heart failure and serve as the basis of treatment guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing Chemotherapy for Cancer Treatment
  • Provided Written Informed Consent

Exclusion criteria

  • Contraindication to Magnetic Resonance Imaging
  • Pregnancy

Treatment and study plan

MyoStrain

Diagnostic Test

MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.

Primary outcomes

  1. Accuracy of MyoStrain to Detect Cardiotoxicity

    Time frame: 6 months

    Sensitivity of MyoStrain CMR Software to quantify myocardial dysfunction before changes in traditional measures including ejection fraction as ascertained by Biomarkers including BNP, Troponin, and SF-36 Quality of Life. Sensitivity will be calculated by looking at paired t-test evaluations comparing follow-up time points to baseline as to whether changes associated with administration of chemotherapy agents and/or heart failure therapy are detected.

Secondary outcomes

  1. Cardiotoxicity Incidence of Chemotherapy Drugs

    Time frame: 6 months

    Incidence of subclinical dysfunction during chemotherapy as determined by CMR detection of the amount and locations of declining segmental myocardial contraction with MyoStrain software that measured the ability of the myocardium to contract in 37 segments of the heart (16 longitudinal strain measurements from 3 short axis planes & 21 circumferential strain segments from 3 long-axis planes).

  2. Efficacy of Heart Failure Therapy to Treat Cardiotoxicity

    Time frame: 6 months

    Impact of heart failure medications to improve subclinical dysfunction, calculated by improvement in previously worsened segmental myocardial contraction with MyoStrain software that measured the ability of the myocardium to contract in 37 segments of the heart (16 longitudinal strain measurements from 3 short axis planes & 21 circumferential strain segments from 3 long-axis planes).

  3. Cardiotoxicity Risk Stratification

    Time frame: 6 months

    Ability to detect risk of developing cardiotoxicity by quantifying subclinical myocardial dysfunction in patients with segmental strain at baseline exceeding predefined thresholds. Higher risk patients will be defined as 2 or more segments > -10% with MyoStrain measurements OR 9 or more segments > -17%; Lower risk patients will be the remaining patients. The changes in strain for each patient category will be evaluated by changes in segmental strain during oncology therapy.

Sponsors and collaborators

Lead sponsor

Myocardial Solutions

Industry

Registry information

Official study title

Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity

Acronym: Prefect

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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