NCT03638271

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
3.1 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 29, 2021

Status Verified

October 1, 2020

Enrollment Period

Same day

First QC Date

June 20, 2018

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    Within two year

  • 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.

    Within two year

  • 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.

    Within two year

  • Assessment of cardiac function.

    Calculation of ejection fraction in percentage.

    Within two years

Secondary Outcomes (1)

  • Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types.

    Within two years

Study Arms (1)

nonischemic cardiomyopathic patient

OTHER

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

Diagnostic Test: Cardiac magnetic resonance imaging

Interventions

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.

nonischemic cardiomyopathic patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 17916581BACKGROUND
  • 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.

    PMID: 16567565BACKGROUND
  • 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.

    PMID: 15998698BACKGROUND
  • 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.

    PMID: 22282181BACKGROUND
  • 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.

    PMID: 10442682BACKGROUND
  • 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.

    PMID: 23741058BACKGROUND
  • 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.

    PMID: 18325368BACKGROUND
  • 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.

    PMID: 19356498BACKGROUND
  • 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.

    PMID: 19808515BACKGROUND
  • 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.

    PMID: 10464806BACKGROUND
  • 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.

    PMID: 11452080BACKGROUND
  • Scott AD, Keegan J, Firmin DN. Motion in cardiovascular MR imaging. Radiology. 2009 Feb;250(2):331-51. doi: 10.1148/radiol.2502071998.

    PMID: 19188310BACKGROUND
  • 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.

    PMID: 20513610BACKGROUND
  • 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.

    PMID: 12821550BACKGROUND
  • 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.

    PMID: 27438188BACKGROUND

Study Officials

  • Reham Sameeh, assistant lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

. Samya Abd El.Aziz, Prof

CONTACT

Moustafa Hashem, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

June 20, 2018

First Posted

August 20, 2018

Study Start

October 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

September 29, 2021

Record last verified: 2020-10