AzTrials
AzTrials

Cardiac FailureNCT03825224

Evaluation of MyoStrain™ in Clinical Practice

An observational study of Cardiac Failure and Coronary Artery Disease, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice Read more about this study

Who is it for?
Any age
What is being tested?
Diagnostic Test: Myostrain
Type of treatment
Surgery or procedure
How many people
19 participants
Where
1 siteUnited States
Study dates
15 Apr 2019to 15 Nov 2019
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Population will consist of patients scheduled for diagnostic testing with cardiac MRI

Who may be able to join

  • Patients already scheduled for diagnostic testing with commercially available imaging modality (cardiac MRI)
  • The patient population will include (but not limited to), those being evaluated for heart disease and heart failure that may be related to vascular disease (coronary artery disease), drug related heart failure (chemotherapy, alcohol), inflammatory systemic conditions (sarcoidosis, amyloidosis, lupus), myocarditis, and/or infectious etiologies
  • Provided written informed consent

Who cannot join

  • Contraindication to Magnetic Resonance Imaging

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice

Read the detailed description

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice to determine how the use may alter treatment decisions and clinical outcomes in patients who are undergoing cardiac MRI.

Being tested
Diagnostic Test: Myostrain
Keywords
MRI, SENC MyoStrain
Medical subject headings
Heart Failure, Coronary Artery Disease, Sarcoidosis, Amyloidosis, Myocarditis, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic Test: MyostrainProcedure or surgery

    This test measures the contraction of the heart muscle in one to three heartbeats per plane. It's a pulse sequence that produces images that reveal the underlying contraction fo the muscle of a healthy heart and associated weaknesses in case of disease.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate workflow for MyoStrain testing

    Survey the CMR interpreter to see how Myostrain impacted their interpretation and survey the referring clinician after receiving the CMR report.

    Survey Questions using 5-point Likert and binary reporting scale. The lower numbers represent positive feedback. Example listed below:

    CARDIAC MRI INTERPRETATION QUESTIONS FOR READER (CARDIOLOGIST OR RADIOLOGIST)

    How easy was it to interpret the additional Myostrain sequence information? 1 2 3 4 5

    (1=Very Helpful 2=Helpful 3=Indifferent 4=Unhelpful 5=Very Unhelpful)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start15 Apr 2019
  3. Primary completion15 Nov 2019
  4. Study completion15 Nov 2019

Resources

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03825224
Sponsor's protocol ID
STUDY00142902
Status last verified
Nov 2019
First submitted
4 Jan 2019
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Korosoglou G, Youssef AA, Bilchick KC, Ibrahim el-S, Lardo AC, Lai S, Osman NF. Real-time fast strain-encoded magnetic resonance imaging to evaluate regional myocardial function at 3.0 Tesla: comparison to conventional tagging. J Magn Reson Imaging. 2008 May;27(5):1012-8. doi: 10.1002/jmri.21315.

    PubMed 18407541

  • Sugimori H, Oyama-Manabe N, Ishizaka K, Hamaguchi H, Sakata M. Comparison of SPAMM and SENC methods for evaluating peak circumferential strain at 3T. Magn Reson Med Sci. 2013 Mar 25;12(1):69-75. doi: 10.2463/mrms.2012-0045. Epub 2013 Mar 11.

    PubMed 23474965

  • Ohyama Y, Ambale-Venkatesh B, Chamera E, Shehata ML, Corona-Villalobos CP, Zimmerman SL, Hassoun PM, Bluemke DA, Lima JAC. Comparison of strain measurement from multimodality tissue tracking with strain-encoding MRI and harmonic phase MRI in pulmonary hypertension. Int J Cardiol. 2015 Mar 1;182:342-348. doi: 10.1016/j.ijcard.2015.01.016. Epub 2015 Jan 6.

    PubMed 25590963

  • Altiok E, Neizel M, Tiemann S, Krass V, Becker M, Zwicker C, Koos R, Kelm M, Kraemer N, Schoth F, Marx N, Hoffmann R. Layer-specific analysis of myocardial deformation for assessment of infarct transmurality: comparison of strain-encoded cardiovascular magnetic resonance with 2D speckle tracking echocardiography. Eur Heart J Cardiovasc Imaging. 2013 Jun;14(6):570-8. doi: 10.1093/ehjci/jes229. Epub 2012 Nov 12.

    PubMed 23148082

  • Korosoglou G, Gitsioudis G, Voss A, Lehrke S, Riedle N, Buss SJ, Zugck C, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac magnetic resonance during high-dose dobutamine stress testing for the estimation of cardiac outcomes: comparison to clinical parameters and conventional wall motion readings. J Am Coll Cardiol. 2011 Sep 6;58(11):1140-9. doi: 10.1016/j.jacc.2011.03.063.

    PubMed 21884952

  • Korosoglou G, Lehrke S, Wochele A, Hoerig B, Lossnitzer D, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded CMR for the detection of inducible ischemia during intermediate stress. JACC Cardiovasc Imaging. 2010 Apr;3(4):361-71. doi: 10.1016/j.jcmg.2009.11.015.

    PubMed 20394897

  • Korosoglou G, Lossnitzer D, Schellberg D, Lewien A, Wochele A, Schaeufele T, Neizel M, Steen H, Giannitsis E, Katus HA, Osman NF. Strain-encoded cardiac MRI as an adjunct for dobutamine stress testing: incremental value to conventional wall motion analysis. Circ Cardiovasc Imaging. 2009 Mar;2(2):132-40. doi: 10.1161/CIRCIMAGING.108.790105. Epub 2009 Jan 26.

    PubMed 19808579

  • Korosoglou G, Futterer S, Humpert PM, Riedle N, Lossnitzer D, Hoerig B, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac MR during high-dose dobutamine stress testing: comparison to cine imaging and to myocardial tagging. J Magn Reson Imaging. 2009 May;29(5):1053-61. doi: 10.1002/jmri.21759.

    PubMed 19388131

  • Korosoglou G, Giusca S, Gitsioudis G, Erbel C, Katus HA. Cardiac magnetic resonance and computed tomography angiography for clinical imaging of stable coronary artery disease. Diagnostic classification and risk stratification. Front Physiol. 2014 Aug 6;5:291. doi: 10.3389/fphys.2014.00291. eCollection 2014.

    PubMed 25147526

  • Neizel M, Korosoglou G, Lossnitzer D, Kuhl H, Hoffmann R, Ocklenburg C, Giannitsis E, Osman NF, Katus HA, Steen H. Impact of systolic and diastolic deformation indexes assessed by strain-encoded imaging to predict persistent severe myocardial dysfunction in patients after acute myocardial infarction at follow-up. J Am Coll Cardiol. 2010 Sep 21;56(13):1056-62. doi: 10.1016/j.jacc.2010.02.070.

    PubMed 20846606

  • Neizel M, Lossnitzer D, Korosoglou G, Schaufele T, Peykarjou H, Steen H, Ocklenburg C, Giannitsis E, Katus HA, Osman NF. Strain-encoded MRI for evaluation of left ventricular function and transmurality in acute myocardial infarction. Circ Cardiovasc Imaging. 2009 Mar;2(2):116-22. doi: 10.1161/CIRCIMAGING.108.789032. Epub 2009 Jan 26.

    PubMed 19808577

  • Koos R, Altiok E, Doetsch J, Neizel M, Krombach G, Marx N, Hoffmann R. Layer-specific strain-encoded MRI for the evaluation of left ventricular function and infarct transmurality in patients with chronic coronary artery disease. Int J Cardiol. 2013 Jun 5;166(1):85-9. doi: 10.1016/j.ijcard.2011.10.004. Epub 2011 Nov 8.

    PubMed 22071039

  • Oyama-Manabe N, Ishimori N, Sugimori H, Van Cauteren M, Kudo K, Manabe O, Okuaki T, Kamishima T, Ito YM, Tsutsui H, Tha KK, Terae S, Shirato H. Identification and further differentiation of subendocardial and transmural myocardial infarction by fast strain-encoded (SENC) magnetic resonance imaging at 3.0 Tesla. Eur Radiol. 2011 Nov;21(11):2362-8. doi: 10.1007/s00330-011-2177-4. Epub 2011 Jun 18.

    PubMed 21688005

  • Youssef A, Ibrahim el-SH, Korosoglou G, Abraham MR, Weiss RG, Osman NF. Strain-encoding cardiovascular magnetic resonance for assessment of right-ventricular regional function. J Cardiovasc Magn Reson. 2008 Jul 4;10(1):33. doi: 10.1186/1532-429X-10-33.

    PubMed 18601713

  • Shehata ML, Basha TA, Tantawy WH, Lima JA, Vogel-Claussen J, Bluemke DA, Hassoun PM, Osman NF. Real-time single-heartbeat fast strain-encoded imaging of right ventricular regional function: normal versus chronic pulmonary hypertension. Magn Reson Med. 2010 Jul;64(1):98-106. doi: 10.1002/mrm.22408.

    PubMed 20572146

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Failure and Coronary Artery Disease, run by University of Kansas Medical Center 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 3 inclusion and 1 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 19 Nov 2019. 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.

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?

Evaluate workflow for MyoStrain testing (time frame: Baseline). 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 NCT03825224, which also lists 18 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 19 Nov 2019.

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