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Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy

Primary Purpose

Cardiac Magnetic Resonance Imaging in Non Ischemic Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiac magnetic resonance imaging
Sponsored by
Reham Sameeh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Magnetic Resonance Imaging in Non Ischemic Cardiomyopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in different sex and age groups with any type of cardiomyopathy and others non cardiomyopathic cases

Exclusion Criteria:

  • Non compatible implantable devices with magnetic resonance machine in some cases as presence of anti para-magnetic substance as pacemakers.
  • In severely ill patients as severe renal impairment (risk of nephrogenic systemic fibrosis)
  • Those with sever claustrophobia.
  • Dysrhythmia affecting ECG-gating.
  • Early pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    nonischemic cardiomyopathic patient

    Arm Description

    Patients in different sex and age groups diagnosed with any type of nonischemic cardiomyopathy clinically or with echocardiography will undergo cardiac magnetic resonance imaging.

    Outcomes

    Primary Outcome Measures

    Cardiac morphological measurements.
    Detection of cardiac wall thickness and ventricular systolic/diastolic diameters. all these measures in millimeters using cardiac magnetic resonance and compare results with echocardiography.
    Cardiac contractility of each part
    Visual assessment of cardiac motility in term of normo- , hypo-, or dys-kinesia using cardiac magnetic resonance and compare results with echocardiography.
    Measurements of severity and prognosis of nonischemic cardiomyopathic patients
    Detection of cardiac muscle replacement and fibrosis by delayed myocardial enhancement using cardiac magnetic resonance, which is indicator of severity and prognosis of disease.
    Assessment of cardiac function.
    Calculation of ejection fraction in percentage.

    Secondary Outcome Measures

    Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types.
    Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types according to previous measures.

    Full Information

    First Posted
    June 20, 2018
    Last Updated
    September 28, 2021
    Sponsor
    Reham Sameeh
    Collaborators
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03638271
    Brief Title
    Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy
    Official Title
    Role of Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Reham Sameeh
    Collaborators
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Cardiac magnetic resonance imaging has been established as a promising three dimensional imaging modality with the ability to assess cardiac morphology, ventricular function, perfusion, viability and imaging characteristics of the surrounding vasculature without ionizing radiation. The accurate treatment of patients with cardiac disorders has created the need for accurate and reproducible measurements of cardiac chamber volumes and function. Cardiac magnetic resonance has the ability to provide this information as well as assess edema, perfusion, viability and vascular anatomy.
    Detailed Description
    Nonischemic cardiomyopathy is considered as a variety of structural and functional myocardial disorders in which the myocardium is abnormal in the absence of diseases such as hypertension and coronary artery, valvular, and congenital heart diseases. Classification of cardiomyopathies is complex, with many available systems. The American Heart Association broadly divides them into primary and secondary types. The European Society of Cardiology classifies cardiomyopathies into several distinct morphologic and functional phenotypes, each of which can be further subclassified into familial and nonfamilial forms . There is an overlap between genetic and acquired cardiomyopathies, especially in the category of dilated cardiomyopathies. Cardiomyopathy has a prevalence of 0.02% of the population with annual death rates up to 25,000 in the United States. Nonischemic cardiomyopathy is more common in younger individuals and women. Although echocardiography is the simplest imaging technique used for screening, diagnosis and classification of cardiomyopathies on the basis of morphology, it is operator dependent , has no tissue characterization capabilities and limited field of view especially in obese/chronic obstructive pulmonary disease patients, influenced by acoustic window, is not adequate in the evaluation of the right ventricle or extra-cardiac associated chest manifestations where magnetic resonance is superior in this issue . Transesophageal echocardiography has a better acoustic window, but it is an invasive procedure. In comparison, cardiac multidetector computed tomography is less useful for the assessment of such cases currently because multidetector computed tomography involves radiation exposure and contrast medium- related problems and provides less information (ie, hemodynamic information, tissue characterization such as fibrosis) than magnetic resonance imaging does. Computed tomography would be more appropriate in specific requests to detect coronary calcification, exclude coronary artery disease and in those cases with contraindications for magnetic resonance imaging, such as a pacemaker. Cardiac magnetic resonance imaging has been established as the best three dimensional imaging modality with the ability to assess cardiac morphology, ventricular function, perfusion, viability and imaging characteristics of the surrounding vasculature without ionizing radiation. The accurate treatment of patients with cardiac disorders has created the need for accurate and reproducible measurements of cardiac chamber volumes and function. Cardiac magnetic resonance has the ability to provide this information as well as assess oedema, perfusion, viability and vascular anatomy. The high soft-tissue contrast, availability of a large field of view, multiplanar acquisition capability and lack of ionizing radiation are particularly appealing features of Cardiac magnetic resonance. There are certain technical challenges unique to cardiac magnetic resonance image as rapid and complex motion of the heart and pulsations of the surrounding great vessels. In addition, the effects of respiratory motion and systolic ventricular blood velocities up to 200 cm/s further complicate cardiac imaging. These challenges are generally solved by implementation of electrocardiography (cardiac) gating; navigator echo respiratory gating; breath-hold techniques; rapid, high-performance gradients; improved field homogeneity; and advanced pulse sequences. electrocardiography gating can be either prospective or retrospective. Several Cardiac magnetic resonance sequences are available for the evaluation of Nonischemic cardiomyopathy, each providing specific information. Depending on the clinical suspicion, the cardiac imager can add specific sequences to form a Cardiac magnetic resonance protocol tailored to that particular disease process. Delayed myocardial enhancement, being one of cardiac magnetic resonance imaging sequences, is not specific for myocardial infarction and can be used in many other cardiac diseases. Delayed enhancement in nonischemic myocardial disease generally, unlike in ischemic heart disease, has no particular coronary artery distribution and is often midwall rather than subendocardial or transmural . Moreover, in the acute phase, the first-pass perfusion study usually does not show any focal perfusion defect in nonischemic cardiomyopathy but instead may show normal results or early increased enhancement. Cardiac magnetic resonance has now established itself as a crucial imaging technique in the evaluation of several cardiomyopathies. It not only provides comprehensive information on structure and function, but also can perform tissue characterization, which helps in establishing the etiology of cardiomyopathy. Cardiac magnetic resonance is also useful in establishing the diagnosis, providing guidance for endomyocardial biopsy, accurate quantification of function, volumes, and fibrosis, prognostic determination, risk stratification, and monitoring response to therapy. One of the most important added points in in investigator(s) research is to assess extra cardiac chest manifestation in by one session of magnetic resonance imaging session with high accuracy and least cost. Echocardiography is the best available gold standard for cardiomyopathic patient as in multiple previous studies, so it well be done for each patient in investigator(s) study for comparison.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Magnetic Resonance Imaging in Non Ischemic Cardiomyopathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    prospective manner study will include 50 patients of both sex and different age with any type of cardiomyopathy diagnosed clinically or by Doppler echocardiography, will undergo cardiac magnetic resonance.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nonischemic cardiomyopathic patient
    Arm Type
    Other
    Arm Description
    Patients in different sex and age groups diagnosed with any type of nonischemic cardiomyopathy clinically or with echocardiography will undergo cardiac magnetic resonance imaging.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Cardiac magnetic resonance imaging
    Intervention Description
    Patients in different sex and age groups diagnosed with any type of nonischemic cardiomyopathy clinically or with echocardiography will undergo cardiac magnetic resonance imaging and compare their results.
    Primary Outcome Measure Information:
    Title
    Cardiac morphological measurements.
    Description
    Detection of cardiac wall thickness and ventricular systolic/diastolic diameters. all these measures in millimeters using cardiac magnetic resonance and compare results with echocardiography.
    Time Frame
    Within two year
    Title
    Cardiac contractility of each part
    Description
    Visual assessment of cardiac motility in term of normo- , hypo-, or dys-kinesia using cardiac magnetic resonance and compare results with echocardiography.
    Time Frame
    Within two year
    Title
    Measurements of severity and prognosis of nonischemic cardiomyopathic patients
    Description
    Detection of cardiac muscle replacement and fibrosis by delayed myocardial enhancement using cardiac magnetic resonance, which is indicator of severity and prognosis of disease.
    Time Frame
    Within two year
    Title
    Assessment of cardiac function.
    Description
    Calculation of ejection fraction in percentage.
    Time Frame
    Within two years
    Secondary Outcome Measure Information:
    Title
    Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types.
    Description
    Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types according to previous measures.
    Time Frame
    Within two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in different sex and age groups with any type of cardiomyopathy and others non cardiomyopathic cases Exclusion Criteria: Non compatible implantable devices with magnetic resonance machine in some cases as presence of anti para-magnetic substance as pacemakers. In severely ill patients as severe renal impairment (risk of nephrogenic systemic fibrosis) Those with sever claustrophobia. Dysrhythmia affecting ECG-gating. Early pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    . Samya Abd El.Aziz, Prof
    Phone
    01006788053
    Email
    samy5abdelaziz@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moustafa Hashem, Prof.
    Phone
    01000684012
    Email
    hashemradiol@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reham Sameeh, assistant lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17916581
    Citation
    Elliott P, Andersson B, Arbustini E, Bilinska Z, Cecchi F, Charron P, Dubourg O, Kuhl U, Maisch B, McKenna WJ, Monserrat L, Pankuweit S, Rapezzi C, Seferovic P, Tavazzi L, Keren A. Classification of the cardiomyopathies: a position statement from the European Society Of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2008 Jan;29(2):270-6. doi: 10.1093/eurheartj/ehm342. Epub 2007 Oct 4.
    Results Reference
    background
    PubMed Identifier
    16567565
    Citation
    Maron BJ, Towbin JA, Thiene G, Antzelevitch C, Corrado D, Arnett D, Moss AJ, Seidman CE, Young JB; American Heart Association; Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; Council on Epidemiology and Prevention. Contemporary definitions and classification of the cardiomyopathies: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; and Council on Epidemiology and Prevention. Circulation. 2006 Apr 11;113(14):1807-16. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.
    Results Reference
    background
    PubMed Identifier
    15998698
    Citation
    Fuster V, Kim RJ. Frontiers in cardiovascular magnetic resonance. Circulation. 2005 Jul 5;112(1):135-44. doi: 10.1161/01.CIR.0000155618.37779.A0. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22282181
    Citation
    O'Donnell DH, Abbara S, Chaithiraphan V, Yared K, Killeen RP, Martos R, Keane D, Cury RC, Dodd JD. Cardiac MR imaging of nonischemic cardiomyopathies: imaging protocols and spectra of appearances. Radiology. 2012 Feb;262(2):403-22. doi: 10.1148/radiol.11100284. Erratum In: Radiology. 2015 Oct;277(1):308.
    Results Reference
    background
    PubMed Identifier
    10442682
    Citation
    Follath F. Nonischemic heart failure: epidemiology, pathophysiology, and progression of disease. J Cardiovasc Pharmacol. 1999 Jun;33 Suppl 3:S31-5. doi: 10.1097/00005344-199906003-00004.
    Results Reference
    background
    PubMed Identifier
    23741058
    Citation
    WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    18325368
    Citation
    Williams TJ, Manghat NE, McKay-Ferguson A, Ring NJ, Morgan-Hughes GJ, Roobottom CA. Cardiomyopathy: appearances on ECG-gated 64-detector row computed tomography. Clin Radiol. 2008 Apr;63(4):464-74. doi: 10.1016/j.crad.2007.07.024. Epub 2007 Nov 5.
    Results Reference
    background
    PubMed Identifier
    19356498
    Citation
    Pohost GM. The history of cardiovascular magnetic resonance. JACC Cardiovasc Imaging. 2008 Sep;1(5):672-8. doi: 10.1016/j.jcmg.2008.07.009. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19808515
    Citation
    Marwick TH, Schwaiger M. The future of cardiovascular imaging in the diagnosis and management of heart failure, part 1: tasks and tools. Circ Cardiovasc Imaging. 2008 Jul;1(1):58-69. doi: 10.1161/CIRCIMAGING.108.792408. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10464806
    Citation
    Boxt LM. Cardiac MR imaging: a guide for the beginner. Radiographics. 1999 Jul-Aug;19(4):1009-25; discussion 1026-8. doi: 10.1148/radiographics.19.4.g99jl161009.
    Results Reference
    background
    PubMed Identifier
    11452080
    Citation
    Reeder SB, Du YP, Lima JA, Bluemke DA. Advanced cardiac MR imaging of ischemic heart disease. Radiographics. 2001 Jul-Aug;21(4):1047-74. doi: 10.1148/radiographics.21.4.g01jl281047.
    Results Reference
    background
    PubMed Identifier
    19188310
    Citation
    Scott AD, Keegan J, Firmin DN. Motion in cardiovascular MR imaging. Radiology. 2009 Feb;250(2):331-51. doi: 10.1148/radiol.2502071998.
    Results Reference
    background
    PubMed Identifier
    20513610
    Citation
    American College of Cardiology Foundation Task Force on Expert Consensus Documents; Hundley WG, Bluemke DA, Finn JP, Flamm SD, Fogel MA, Friedrich MG, Ho VB, Jerosch-Herold M, Kramer CM, Manning WJ, Patel M, Pohost GM, Stillman AE, White RD, Woodard PK. ACCF/ACR/AHA/NASCI/SCMR 2010 expert consensus document on cardiovascular magnetic resonance: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. J Am Coll Cardiol. 2010 Jun 8;55(23):2614-62. doi: 10.1016/j.jacc.2009.11.011. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12821550
    Citation
    McCrohon JA, Moon JC, Prasad SK, McKenna WJ, Lorenz CH, Coats AJ, Pennell DJ. Differentiation of heart failure related to dilated cardiomyopathy and coronary artery disease using gadolinium-enhanced cardiovascular magnetic resonance. Circulation. 2003 Jul 8;108(1):54-9. doi: 10.1161/01.CIR.0000078641.19365.4C. Epub 2003 Jun 23.
    Results Reference
    background
    PubMed Identifier
    27438188
    Citation
    Rajiah P, Raza S, Saboo SS, Ghoshhajra B, Abbara S. Update on the Role of Cardiac Magnetic Resonance in Acquired Nonischemic Cardiomyopathies. J Thorac Imaging. 2016 Nov;31(6):348-366. doi: 10.1097/RTI.0000000000000226.
    Results Reference
    background

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