Hypertrophic CardiomyopathyNCT02234336
Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Noncontrast echocardiography, Contrast Echocardiography and Cardiac magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 25 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with hypertrophic cardiomyopathy (HCM)
Who may be able to join
- 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
Who cannot join
- 1) Insufficient image quality for determination of maximal wall thickness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance imaging at Mayo Clinic will be eligible.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Noncontrast echocardiography, Contrast Echocardiography, Cardiac magnetic resonance imaging
- Keywords
- Echocardiography, hypertrophic cardiomyopathy, cardiomyopathy, magnetic resonance imaging, contrast
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noncontrast echocardiographyProcedure or surgery
Contrast EchocardiographyProcedure or surgery
Cardiac magnetic resonance imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Subjects with HCM | All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI. Receives: Procedure: Noncontrast echocardiography; Procedure: Contrast Echocardiography; Procedure: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Wall Thickness
All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.
Measured: approximately 1 week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Patricia A. Pellikka, Mayo Clinic
- Investigators
- Patricia Pellikka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234336
- Sponsor's protocol ID
- 14-004757
- Status last verified
- Feb 2019
- First submitted
- 5 Sep 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02234336
- Acronym / sponsor ID
- 14-004757
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Echocardiography, hypertrophic cardiomyopathy, cardiomyopathy, magnetic resonance imaging, contrast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Oct 2014
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance imaging at Mayo Clinic will be eligible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with HCM | – | Procedure: Noncontrast echocardiography, Procedure: Contrast Echocardiography, Procedure: Cardiac magnetic resonance imagingAll subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with hypertrophic cardiomyopathy (HCM)
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- 1) Insufficient image quality for determination of maximal wall thickness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noncontrast echocardiography | Procedure or surgery | Subjects with HCM |
| Contrast Echocardiography | Procedure or surgery | Subjects with HCM |
| Cardiac magnetic resonance imaging | Procedure or surgery | Subjects with HCM |
Primary outcome
Left Ventricular Wall Thickness
Time frame: approximately 1 week after enrollment
All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Pellikka, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Wall Thickness (time frame: approximately 1 week after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.