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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02234336
Other study ID # 14-004757
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date July 25, 2017

Study information

Verified date February 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 25, 2017
Est. primary completion date July 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Noncontrast echocardiography

Contrast Echocardiography

Cardiac magnetic resonance imaging


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left Ventricular Wall Thickness All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI. approximately 1 week after enrollment
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