Hypertrophic CardiomyopathyNCT03150342
Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
An observational study of Hypertrophic Cardiomyopathy and Myocardial Perfusion Imaging, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease imaging time and improved the imaging quality… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Myocardial Perfusion Imaging
- What is being tested?
- myocardial perfusion imaging
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 May 2017to 30 Jun 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCM patients with patent coronary artery who underwent MPI
Who may be able to join
- clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016.
Who cannot join
- patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Szu-Ying Tsai, MD, +886289667000 ext. 1223, dorissyt@mail.femh.org.tw
About this study
Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI). The investigators also correlate the MPI parameters with echocardiographic parameters. This study is to examine the spatial distribution of stress perfusion abnormalities and tissue injury in patients with HCM using a CZT SPECT camera.
Read the detailed description
The investigators will retrospectively evaluate myocardial perfusion patterns and cardiac function with Thallium (Tl)-201 gated dipyridamole MPI in patients with clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016. The inclusion criteria included a spade-like configuration on left ventriculogram, or echocardiographic findings suggestive of HCM. The participants will be then divided into the following three groups: apical, concentric and septal forms. Regional perfusion would be analyzed using a 17-segment model from 0-4 degree (0=normal, to 4=absent perfusion); and summed stress score (SSS), summed rest score (SRS) and summed difference score (SDS) were calculated. Gated SPECT would be processed by quantitative gated SPECT (QGS) software (Cedars-Sinai Medical Center, Los Angeles, CA, USA) and ejection fraction phase analysis. Diastolic parameters would be also acquired by Doppler echocardiography, and correlated with MPI parameters.
- Being tested
- myocardial perfusion imaging
- Keywords
- CZT scanner, myocardial perfusion imaging, Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial perfusion imagingDiagnostic test
dipyridamole-stressed MPI scan using thallium-201
What is being measured
The primary outcome is the main question the study is designed to answer.
MPI results
including perfusion abnormalities, and ejection fraction phase analysis results
Measured: January 2013 and October 2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start8 May 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szu-Ying Tsai, Far Eastern Memorial Hospital
- Investigators
- Yen-Wen Wu, MD, PhD, Study director, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150342
- Sponsor's protocol ID
- 106057-E
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
- ClinicalTrials.gov ID
- NCT03150342
- Acronym / sponsor ID
- 106057-E
- Keywords
- CZT scanner, myocardial perfusion imaging, Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 May 2017 (actual)
- 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.
Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI). The investigators also correlate the MPI parameters with echocardiographic parameters. This study is to examine the spatial distribution of stress perfusion abnormalities and tissue injury in patients with HCM using a CZT SPECT camera.
Detailed description
The investigators will retrospectively evaluate myocardial perfusion patterns and cardiac function with Thallium (Tl)-201 gated dipyridamole MPI in patients with clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016. The inclusion criteria included a spade-like configuration on left ventriculogram, or echocardiographic findings suggestive of HCM. The participants will be then divided into the following three groups: apical, concentric and septal forms. Regional perfusion would be analyzed using a 17-segment model from 0-4 degree (0=normal, to 4=absent perfusion); and summed stress score (SSS), summed rest score (SRS) and summed difference score (SDS) were calculated. Gated SPECT would be processed by quantitative gated SPECT (QGS) software (Cedars-Sinai Medical Center, Los Angeles, CA, USA) and ejection fraction phase analysis. Diastolic parameters would be also acquired by Doppler echocardiography, and correlated with MPI parameters.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCM patients with patent coronary artery who underwent MPI
Key inclusion criteria (1 listed)
- clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016.
Key exclusion criteria (1 listed)
- patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy
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 |
|---|---|---|
| myocardial perfusion imagingdipyridamole-stressed MPI scan using thallium-201 | Diagnostic test | – |
Primary outcome
MPI results
Time frame: January 2013 and October 2016.
including perfusion abnormalities, and ejection fraction phase analysis results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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.
Yen-Wen Wu, MD, PhD study director
Far Eastern Memorial Hospital
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 and Myocardial Perfusion Imaging, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 16 May 2017. 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 Taiwan. 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?
Contact Szu-Ying Tsai, MD (+886289227000 ext. 1223, dorissyt@mail.femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPI results (time frame: January 2013 and October 2016.). 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 16 May 2017.