Ventricular DysfunctionNCT02644850
Comparison of Gated Blood-pool SPECT and Echocardiogram for Ventricular Function
An observational study of Ventricular Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ventricular Dysfunction
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to Dec 2018
- How long will I take part?
- 3 Years
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other
Who may be able to join
- Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital and National Taiwan University College of Medicine
Taipei, 100
Mei-Fang Cheng, M.D., 886-2-23123456 ext. 65575, meifang@ntuh.gov.tw
About this study
Official title: Comparison of Gated Blood-pool SPECT Using CZT Camera and Echocardiogram for Ventricular Ejection Fraction Estimation
To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.
Read the detailed description
To evaluate the feasibility of using CZT SPECT as an "all-in-one" technique to provide information on both left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) derived from a single examination and compare with the values from traditional planar ERNA, FP-RNV and echocardiography.
- Conditions
- Ventricular Dysfunction
- Medical subject headings
- Ventricular Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the biventricular ejection fraction
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Fang Cheng, M.D., Principal investigator, National Taiwan University Hospital and National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644850
- Sponsor's protocol ID
- 201508081RINA
- Status last verified
- Dec 2015
- First submitted
- 29 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gated Blood-pool SPECT Using CZT Camera and Echocardiogram for Ventricular Ejection Fraction Estimation
- ClinicalTrials.gov ID
- NCT02644850
- Acronym / sponsor ID
- 201508081RINA
- Conditions
- Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Jan 2016 (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.
To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.
Detailed description
To evaluate the feasibility of using CZT SPECT as an "all-in-one" technique to provide information on both left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) derived from a single examination and compare with the values from traditional planar ERNA, FP-RNV and echocardiography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other
Key inclusion criteria (1 listed)
- Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the biventricular ejection fraction
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Individual participant dataSharing planned: No
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Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
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Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
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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.
Mei-Fang Cheng, M.D. principal investigator
National Taiwan University Hospital and National Taiwan University College of Medicine
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 Ventricular Dysfunction, run by National Taiwan University 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 1 Jan 2016. 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 Mei-Fang Cheng, M.D. (886-2-23123456 ext. 65575, meifang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the biventricular ejection fraction (time frame: Through study completion, an average of 3 years). 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 1 Jan 2016.