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Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03638271
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Reham Sameeh, Assiut University

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.

Condition or disease Intervention/treatment Phase
Cardiac Magnetic Resonance Imaging in Non Ischemic Cardiomyopathy Diagnostic Test: Cardiac magnetic resonance imaging Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Role of Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
nonischemic cardiomyopathic patient
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
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 Measures :
  1. Cardiac morphological measurements. [ Time Frame: Within two year ]
    Detection of cardiac wall thickness and ventricular systolic/diastolic diameters. all these measures in millimeters using cardiac magnetic resonance and compare results with echocardiography.

  2. Cardiac contractility of each part [ Time Frame: Within two year ]
    Visual assessment of cardiac motility in term of normo- , hypo-, or dys-kinesia using cardiac magnetic resonance and compare results with echocardiography.

  3. Measurements of severity and prognosis of nonischemic cardiomyopathic patients [ Time Frame: Within two year ]
    Detection of cardiac muscle replacement and fibrosis by delayed myocardial enhancement using cardiac magnetic resonance, which is indicator of severity and prognosis of disease.

  4. Assessment of cardiac function. [ Time Frame: Within two years ]
    Calculation of ejection fraction in percentage.


Secondary Outcome Measures :
  1. Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types. [ Time Frame: Within two years ]
    Diagnosis and differentiation of different types of non-ischemic cardiomyopathic types according to previous measures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638271


Contacts
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Contact: . Samya Abd El.Aziz, Prof 01006788053 samy5abdelaziz@yahoo.com
Contact: Moustafa Hashem, Prof. 01000684012 hashemradiol@yahoo.com

Sponsors and Collaborators
Reham Sameeh
Assiut University
Investigators
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Principal Investigator: Reham Sameeh, assistant lecturer Assiut University

Publications:

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Responsible Party: Reham Sameeh, Assisstant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03638271     History of Changes
Other Study ID Numbers: Non ischemic cardiomyopathy MR
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases