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
About this trial
This is an interventional diagnostic trial for Cardiac Magnetic Resonance Imaging in Non Ischemic Cardiomyopathy
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.
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
NCT ID
NCT03638271
First Posted
June 20, 2018
Last Updated
September 28, 2021
Sponsor
Reham Sameeh
Collaborators
Assiut University
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:
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Cardiac Magnetic Resonance in Non Ischemic Cardiomyopathy
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