CardiotoxicityPrefectNCT03543228
MyoStrain CMR for the Detection of Cardiotoxicity
An observational study of Cardiotoxicity and Heart Failure, run by Myocardial Solutions at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiotoxicity, Heart Failure, Chemotherapeutic Toxicity
- What is being tested?
- MyoStrain
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be carefully selected from the pool of patients currently undergoing or scheduled to undergo chemotherapy for cancer treatment including breast cancer and lymphoma patients.
Who may be able to join
- Undergoing Chemotherapy for Cancer Treatment
- Provided Written Informed Consent
Who cannot join
- Contraindication to Magnetic Resonance Imaging
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prefect Study of 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).
Read the detailed description
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.
- Conditions
- Cardiotoxicity, Heart Failure, Chemotherapeutic Toxicity
- Being tested
- MyoStrain
- Keywords
- Strain
- Medical subject headings
- Cardiotoxicity, Heart Failure, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoStrainDiagnostic test
MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| MyoStrain | During standard chemotherapy and/or targeted treatment for breast cancer or lymphoma, MyoStrain will be used during standard cardiac magnetic resonance imaging to evaluate the change in myocardial contraction regionally and globally to detect cardiotoxicity and management of myocardial dysfunction. Receives: Diagnostic Test: MyoStrain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MyoStrain to Detect Cardiotoxicity
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.
Measured: 6 months
Secondary outcomes (3)
Cardiotoxicity Incidence of Chemotherapy Drugs
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).
Measured: 6 months
Efficacy of Heart Failure Therapy to Treat Cardiotoxicity
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).
Measured: 6 months
Cardiotoxicity Risk Stratification
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Aug 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myocardial Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Steen, MD, Principal investigator, Marien Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543228
- Sponsor's protocol ID
- VAL-1005P(A)
- Acronym
- Prefect
- Status last verified
- Jun 2021
- First submitted
- 17 May 2018
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Giusca S, Korosoglou G, Montenbruck M, Gersak B, Schwarz AK, Esch S, Kelle S, Wulfing P, Dent S, Lenihan D, Steen H. Multiparametric Early Detection and Prediction of Cardiotoxicity Using Myocardial Strain, T1 and T2 Mapping, and Biochemical Markers: A Longitudinal Cardiac Resonance Imaging Study During 2 Years of Follow-Up. Circ Cardiovasc Imaging. 2021 Jun;14(6):e012459. doi: 10.1161/CIRCIMAGING.121.012459. Epub 2021 Jun 15.
PubMed 34126756
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity
- ClinicalTrials.gov ID
- NCT03543228
- Acronym / sponsor ID
- Prefect / VAL-1005P(A)
- Conditions
- Cardiotoxicity, Heart Failure, Chemotherapeutic Toxicity
- Keywords
- Strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Myocardial SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoStrain | – | Diagnostic Test: MyoStrainDuring standard chemotherapy and/or targeted treatment for breast cancer or lymphoma, MyoStrain will be used during standard cardiac magnetic resonance imaging to evaluate the change in myocardial contraction regionally and globally to detect cardiotoxicity and management of myocardial dysfunction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be carefully selected from the pool of patients currently undergoing or scheduled to undergo chemotherapy for cancer treatment including breast cancer and lymphoma patients.
Key inclusion criteria (2 listed)
- Undergoing Chemotherapy for Cancer Treatment
- Provided Written Informed Consent
Key exclusion criteria (2 listed)
- Contraindication to Magnetic Resonance Imaging
- Pregnancy
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 |
|---|---|---|
| MyoStrainMyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy. | Diagnostic test | MyoStrain |
Primary outcome
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.
3 secondary outcomes
Cardiotoxicity Incidence of Chemotherapy Drugs
Time frame: 6 months
Efficacy of Heart Failure Therapy to Treat Cardiotoxicity
Time frame: 6 months
Cardiotoxicity Risk Stratification
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Results publication: PubMed 34126756Giusca S, Korosoglou G, Montenbruck M, Gersak B, Schwarz AK, Esch S, Kelle S, Wulfing P, Dent S, Lenihan D, Steen H. Multiparametric Early Detection and Prediction of Cardiotoxicity Using Myocardial Strain, T1 and T2 Mapping, and Biochemical Markers: A Longitudinal Cardiac Resonance Imaging Study During 2 Years of Follow-Up. Circ Cardiovasc Imaging. 2021 Jun;14(6):e012459. doi: 10.1161/CIRCIMAGING.121.012459. Epub 2021 Jun 15.
- Individual participant dataSharing planned: Undecided
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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.
Henning Steen, MD principal investigator
Marien Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Heart Failure, run by Myocardial Solutions at 1 site in Germany.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2021. 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 Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of MyoStrain to Detect Cardiotoxicity (time frame: 6 months). 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 NCT03543228, which also lists 1 linked publication.
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 25 Jun 2021.