MyoStrain CMR for the Detection of Cardiotoxicity

Heart Failure Clinical Trial

— Prefect  

Official title:

Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543228
• Other study ID #: VAL-1005P(A)
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: Myocardial Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Undergoing Chemotherapy for Cancer Treatment
• Provided Written Informed Consent

Exclusion Criteria:

• Contraindication to Magnetic Resonance Imaging
• Pregnancy

Related Conditions & MeSH terms

• Cardiotoxicity
• Chemotherapeutic Toxicity
• Heart Failure

Intervention

Diagnostic Test:
• MyoStrain
MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.

Locations

Country	Name	City	State
Germany	Marien Krankenhaus GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Myocardial Solutions

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Giusca S, Korosoglou G, Montenbruck M, Geršak B, Schwarz AK, Esch S, Kelle S, Wülfing 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 Lo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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.	6 months