Ireland
--:--IST
Recruiting Observational

A Multi-center Cardiac PYP Scan Registry in Taiwan

NCT05593679 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2022-11-01
Last updated
2024-07-29

Condition(s) studied

Heart FailureCardiac Amyloidosis

Investigational drug(s) / intervention(s)

Tc-99m PYP Cardiac scan

Tc-99m PYP Cardiac scan: Tc-99m PYP Cardiac scan

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Death — 1 year
    Death

Trial sites (1)

FacilityCityRegionStatus
Far Eastern Memorial Hospital New Taipei City Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05593679 on ClinicalTrials.gov ↗ ← All trials in Taiwan