NCT02234336

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

September 5, 2014

Last Update Submit

February 4, 2019

Conditions

Keywords

Echocardiographyhypertrophic cardiomyopathycardiomyopathymagnetic resonance imagingcontrast

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Wall Thickness

    All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.

    approximately 1 week after enrollment

Study Arms (1)

Subjects with HCM

All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.

Procedure: Noncontrast echocardiographyProcedure: Contrast EchocardiographyProcedure: Cardiac magnetic resonance imaging

Interventions

Subjects with HCM
Subjects with HCM
Subjects with HCM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with hypertrophic cardiomyopathy (HCM)

You may qualify if:

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

You may not qualify if:

  • \) Insufficient image quality for determination of maximal wall thickness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Patricia Pellikka, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, College of Medicine

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations