Heart FailureNCT05593679
A Multi-center Cardiac PYP Scan Registry in Taiwan
An observational study of Heart Failure and Cardiac Amyloidosis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Cardiac Amyloidosis
- What is being tested?
- Tc-99m PYP Cardiac scan
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients screened for ATTR-CM
Who may be able to join
- ≥ 20 years of age
- Documented diagnosis or r/o of ATTR amyloidosis
Who cannot join
- Pregnant or nursing (lactating) women.
- Important systemic diseases (except heart disease or neurological diseases) such as liver cirrhosis, active malignant tumors, etc., with a life expectancy of less than 6 months.
- Patient who refused clinical follow up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Yen-Wen Wu, MD, PhD, 886-2-8966-7000 ext. 1090, wuyw0502@gmail.com
Yen-Wen Wu, MD, PhD
About this study
Official title: A Multi-center Registry for Clinical Information and 99mTc-pyrophosphate Scintigraphy in Patients With Suspected Cardiac Amyloidosis in Taiwan
Amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. The most common mutation in Taiwan is A97S, 80% have left ventricular hypertrophy. The good prognosis depends on early diagnosis and correct treatment strategy.
Bone-avid tracers such as 99mTc-PYP/DPD/HMDP could detect CA. The mechanism is not clear yet, which may be related to the microcalcification. AL amyloidosis is mostly between visual score grade 0-2, and ATTR-CM is usually grade≥2 on PYP scan, or heart to contralateral (H/CL) ratio, and it might replace invasive myocardial biopsy. However, there are no large-scale clinical studies, lack of standardization data, and limited information in comparison between clinical and imaging parameters.
The project will enroll patients with suspected or diagnosed with CA according to CA diagnostic algorithm. Clinical data and image parameters are collected and compared. The project aims to set up prediction models based on the multi-parameters of PYP scan using artificial intelligence technology, including imaging registration and alignment technology, and standardization. The investigators further use the key cardiovascular data elements and imaging-derived database using model training network to extract image features to develop the diagnostic and prognostic prediction models, which are expected to validate the clinical significance and improve patient-centric performance and efficient clinical decision making.
Read the detailed description
The investigators will retrospectively and prospectively collect total PYP scans that had been performed on suspected or diagnosed ATTR-CM patients in medical centers in Taiwan and follow-up at least 1 year. You are enrolled based on clinical suspicions such as "red-flag" signs using ultrasound, NT-pro BNP and clinical data according to the diagnostic algorithms. If you are with Grade 2 and 3 PYP myocardial uptake, genetic testing is arranged, serum and urine AL tests results will be confirmed. Before reading, the imaging quality will be evaluated (good quality, fair but interpretable, poor but interpretable, poor and insufficient for interpretation). All the images will be visually graded by experienced nuclear medicine physicians with consensus. It helps understand the real-world data.
- Conditions
- Heart Failure, Cardiac Amyloidosis
- Being tested
- Tc-99m PYP Cardiac scan
- Medical subject headings
- Heart Failure, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc-99m PYP Cardiac scanDiagnostic test
Tc-99m PYP Cardiac scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death
Measured: 1 year
Secondary outcomes (2)
CV death
CV death
Measured: 1 year
Hospitalization for heart failure
Hospitalization for heart failure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Nov 2022
- Primary completion29 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Wen Wu, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593679
- Sponsor's protocol ID
- 111229-E
- Status last verified
- Jul 2024
- First submitted
- 20 Oct 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Registry for Clinical Information and 99mTc-pyrophosphate Scintigraphy in Patients With Suspected Cardiac Amyloidosis in Taiwan
- ClinicalTrials.gov ID
- NCT05593679
- Acronym / sponsor ID
- 111229-E
- Conditions
- Heart Failure, Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Oct 2022 (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.
Amyloid deposition in the heart is called cardiac amyloidosis (CA); 95% is immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Hereditary (ATTRm) or wild-type (ATTRwt) depends on whether the ATTRm gene is mutated or not. The most common mutation in Taiwan is A97S, 80% have left ventricular hypertrophy. The good prognosis depends on early diagnosis and correct treatment strategy.
Bone-avid tracers such as 99mTc-PYP/DPD/HMDP could detect CA. The mechanism is not clear yet, which may be related to the microcalcification. AL amyloidosis is mostly between visual score grade 0-2, and ATTR-CM is usually grade≥2 on PYP scan, or heart to contralateral (H/CL) ratio, and it might replace invasive myocardial biopsy. However, there are no large-scale clinical studies, lack of standardization data, and limited information in comparison between clinical and imaging parameters.
The project will enroll patients with suspected or diagnosed with CA according to CA diagnostic algorithm. Clinical data and image parameters are collected and compared. The project aims to set up prediction models based on the multi-parameters of PYP scan using artificial intelligence technology, including imaging registration and alignment technology, and standardization. The investigators further use the key cardiovascular data elements and imaging-derived database using model training network to extract image features to develop the diagnostic and prognostic prediction models, which are expected to validate the clinical significance and improve patient-centric performance and efficient clinical decision making.
Detailed description
The investigators will retrospectively and prospectively collect total PYP scans that had been performed on suspected or diagnosed ATTR-CM patients in medical centers in Taiwan and follow-up at least 1 year. You are enrolled based on clinical suspicions such as "red-flag" signs using ultrasound, NT-pro BNP and clinical data according to the diagnostic algorithms. If you are with Grade 2 and 3 PYP myocardial uptake, genetic testing is arranged, serum and urine AL tests results will be confirmed. Before reading, the imaging quality will be evaluated (good quality, fair but interpretable, poor but interpretable, poor and insufficient for interpretation). All the images will be visually graded by experienced nuclear medicine physicians with consensus. It helps understand the real-world data.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients screened for ATTR-CM
Key inclusion criteria (2 listed)
- ≥ 20 years of age
- Documented diagnosis or r/o of ATTR amyloidosis
Key exclusion criteria (3 listed)
- Pregnant or nursing (lactating) women.
- Important systemic diseases (except heart disease or neurological diseases) such as liver cirrhosis, active malignant tumors, etc., with a life expectancy of less than 6 months.
- Patient who refused clinical follow up.
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 |
|---|---|---|
| Tc-99m PYP Cardiac scanTc-99m PYP Cardiac scan | Diagnostic test | – |
Primary outcome
Death
Time frame: 1 year
Death
2 secondary outcomes
CV death
Time frame: 1 year
Hospitalization for heart failure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Yen-Wen Wu principal investigator
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 Heart Failure and Cardiac Amyloidosis, 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-Wen Wu (886-2-8966-7000 ext. 1090, wuyw0502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 year). 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 29 Jul 2024.