- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03150342
Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
May 15, 2017 updated by: Szu-Ying Tsai, Far Eastern Memorial Hospital
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Szu-Ying Tsai, MD
- Phone Number: 1223 +886289227000
- Email: dorissyt@mail.femh.org.tw
Study Locations
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-
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New Taipei City, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
-
Contact:
- Szu-Ying Tsai, MD
- Phone Number: 1223 +886289667000
- Email: dorissyt@mail.femh.org.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HCM patients with patent coronary artery who underwent MPI
Description
Inclusion Criteria:
- clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016.
Exclusion Criteria:
- patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MPI results
Time Frame: January 2013 and October 2016.
|
including perfusion abnormalities, and ejection fraction phase analysis results
|
January 2013 and October 2016.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yen-Wen Wu, MD, PhD, Far Eastern Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 8, 2017
Primary Completion (ANTICIPATED)
August 31, 2017
Study Completion (ANTICIPATED)
June 30, 2018
Study Registration Dates
First Submitted
May 10, 2017
First Submitted That Met QC Criteria
May 10, 2017
First Posted (ACTUAL)
May 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106057-E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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