Hypertrophic CardiomyopathyNCT02560467
Perfusion Imaging With Myocardial Contrast Echocardiography in HCM
A study testing Echo and myocardial contrast echocardiography perfusion imaging in people with Hypertrophic Cardiomyopathy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Echo and myocardial contrast echocardiography perfusion imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 15 Sep 2019
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Established diagnosis of HCM
Who cannot join
- Known history of coronary or peripheral artery disease
- History of myocardial infarction
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent
- Evidence right-to-left or bi-directional intracardiac shunt
- Moderate or greater valve disease other than from HCM (systolic anterior motion of the mitral valve)
Show all 9Show fewer
- History of septal ablation or myectomy
- Hemodynamic instability
- Pacemaker dependent heart rhythm
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. A secondary aim will be to determine whether abnormalities in perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence of arrhythmias, and regional function of the septum.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Echo and myocardial contrast echocardiography perfusion imaging
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo and myocardial contrast echocardiography perfusion imagingDrug
Myocardial blood flow will be assessed by myocardial contrast echo. Perfusion at rest and stress will be quantified and compared to patient sx, degree of dysfunction on echo strain imaging, and degree of fibrosis on magnetic resonance imaging (when available) that was ordered as part of routine clinical care.
Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits. Vasodilator stress during MCE imaging will be performed using regadenoson at FDA-approved doses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HCM | Experimental | This is a prospective, non-blinded single center study. Subjects with known HCM with variant will be recruited. MCE at rest and during vasodilator stress will be performed. Full echocardiography including for diastolic function and regional strain imaging will also be performed. Patient history and questionnaires will be used for evaluation of symptoms and arrhythmias. Receives: Drug: Echo and myocardial contrast echocardiography perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo
Myocardial contrast echo will be used to measure myocardial perfusion in ml/min/g of tissue in the hypertrophied segment. The data will be analyzed both in terms of absolute value of ml/min/g and also as a ration to normal tissue.
Measured: One hour
Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo
Myocardial blood flow reserve on myocardial contrast echo (ratio of flow during hyperemia to rest) will be calculated for the hypertrophied segment and expressed as an absolute value and relative to normal segments.
Measured: One hour
Secondary outcomes (1)
Spatial distribution of blood flow on myocardial contrast echocardiography
Myocardial contrast echocardiography performed at baseline will be analyzed using mathematical algorithms that define how "homogenous" or "heterogenous" blood flow distribution is in the hypertrophied segment. These values will be described by wavelet energy levels (dimensionless).
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start1 Dec 2015
- Primary completion1 Sep 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Lindner, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560467
- Sponsor's protocol ID
- 15158
- Status last verified
- Jun 2019
- First submitted
- 22 Sep 2015
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roldan P, Ravi S, Hodovan J, Belcik JT, Heitner SB, Masri A, Lindner JR. Myocardial contrast echocardiography assessment of perfusion abnormalities in hypertrophic cardiomyopathy. Cardiovasc Ultrasound. 2022 Sep 19;20(1):23. doi: 10.1186/s12947-022-00293-2.
PubMed 36117179
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Imaging With Myocardial Contrast Echocardiography in HCM
- ClinicalTrials.gov ID
- NCT02560467
- Acronym / sponsor ID
- 15158
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 25 Sep 2015 (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.
The objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. A secondary aim will be to determine whether abnormalities in perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence of arrhythmias, and regional function of the septum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCM | Experimental | Drug: Echo and myocardial contrast echocardiography perfusion imagingThis is a prospective, non-blinded single center study. Subjects with known HCM with variant will be recruited. MCE at rest and during vasodilator stress will be performed. Full echocardiography including for diastolic function and regional strain imaging will also be performed. Patient history and questionnaires will be used for evaluation of symptoms and arrhythmias. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Established diagnosis of HCM
Key exclusion criteria (9 listed)
- Known history of coronary or peripheral artery disease
- History of myocardial infarction
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent
- Evidence right-to-left or bi-directional intracardiac shunt
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 |
|---|---|---|
| Echo and myocardial contrast echocardiography perfusion imagingMyocardial blood flow will be assessed by myocardial contrast echo. Perfusion at rest and stress will be quantified and compared to patient sx, degree of dysfunction on echo strain imaging, and degree of fibrosis on magnetic resonance imaging (when available) that was ordered as part of routine clinical care. Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits. Vasodilator stress during MCE imaging will be performed using regadenoson at FDA-approved doses. | Drug | Patients with HCM |
Primary outcome
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo
Time frame: One hour
Myocardial contrast echo will be used to measure myocardial perfusion in ml/min/g of tissue in the hypertrophied segment. The data will be analyzed both in terms of absolute value of ml/min/g and also as a ration to normal tissue.
Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo
Time frame: One hour
Myocardial blood flow reserve on myocardial contrast echo (ratio of flow during hyperemia to rest) will be calculated for the hypertrophied segment and expressed as an absolute value and relative to normal segments.
1 secondary outcome
Spatial distribution of blood flow on myocardial contrast echocardiography
Time frame: One hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 36117179Roldan P, Ravi S, Hodovan J, Belcik JT, Heitner SB, Masri A, Lindner JR. Myocardial contrast echocardiography assessment of perfusion abnormalities in hypertrophic cardiomyopathy. Cardiovasc Ultrasound. 2022 Sep 19;20(1):23. doi: 10.1186/s12947-022-00293-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo and myocardial contrast echocardiography perfusion imaging in people with Hypertrophic Cardiomyopathy, run by Oregon Health and Science University 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Jun 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?
Results are not available in the source record.
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?
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo (time frame: One hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560467, which also lists 1 linked publication.
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 6 Jun 2019.