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Assessment of Wall Thickness in Hypertrophic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02234336
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Patricia A. Pellikka, Mayo Clinic

Brief Summary:
Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death. However, data regarding comparison of imaging modalities for this key measurement is lacking. This study seeks to compare assessment of maximum wall thickness between clinically indicated echocardiography (with and without contrast) and clinically indicated cardiac magnetic resonance imaging.

Condition or disease Intervention/treatment
Hypertrophic Cardiomyopathy Procedure: Noncontrast echocardiography Procedure: Contrast Echocardiography Procedure: Cardiac magnetic resonance imaging

Detailed Description:
Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance imaging at Mayo Clinic will be eligible.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Study Start Date : October 2014
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017


Group/Cohort Intervention/treatment
Subjects with HCM
All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.
Procedure: Noncontrast echocardiography
Procedure: Contrast Echocardiography
Procedure: Cardiac magnetic resonance imaging



Primary Outcome Measures :
  1. Left Ventricular Wall Thickness [ Time Frame: approximately 1 week after enrollment ]
    All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with hypertrophic cardiomyopathy (HCM)
Criteria

Inclusion Criteria:

  1. Clinically and echocardiographically defined hypertrophic cardiomyopathy.
  2. Clinically indicated transthoracic echocardiography as part of the medical evaluation.
  3. No contradiction to administration of ultrasonic echocardiography contrast.
  4. Planned clinically indicated cardiac magnetic resonance imaging as part of medical evaluation.
  5. No contraindication to cardiac magnetic resonance imaging (such as cochlear implants, central nervous system aneurysm clips and other implanted medical devices).
  6. Age 18 years and older

Exclusion Criteria:

1) Insufficient image quality for determination of maximal wall thickness.


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): NCT02234336


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
GE Healthcare
Investigators
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Principal Investigator: Patricia Pellikka, MD Mayo Clinic

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Responsible Party: Patricia A. Pellikka, Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02234336     History of Changes
Other Study ID Numbers: 14-004757
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Patricia A. Pellikka, Mayo Clinic:
Echocardiography
hypertrophic cardiomyopathy
cardiomyopathy
magnetic resonance imaging
contrast
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases