NCT05593679 A Multi-center Cardiac PYP Scan Registry in Taiwan
| NCT ID | NCT05593679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Far Eastern Memorial Hospital |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-11-01 with a primary completion date of 2027-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 20 years of age 2. Documented diagnosis or r/o of ATTR amyloidosis Exclusion Criteria: 1. Pregnant or nursing (lactating) women. 2. 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. 3. Patient who refused clinical follow up.
Contact & Investigator
Yen-Wen Wu
PRINCIPAL INVESTIGATOR
Far Eastern Memorial Hospital
Frequently Asked Questions
Who can join the NCT05593679 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05593679 currently recruiting?
Yes, NCT05593679 is actively recruiting participants. Contact the research team at wuyw0502@gmail.com for enrollment information.
Where is the NCT05593679 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT05593679 clinical trial?
NCT05593679 is sponsored by Far Eastern Memorial Hospital. The principal investigator is Yen-Wen Wu at Far Eastern Memorial Hospital. The trial plans to enroll 1,000 participants.
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