A Multi-center Registry for Clinical Information and 99mTc-pyrophosphate Scintigraphy in Patients With Suspected Cardiac Amyloidosis in Taiwan

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• ≥ 20 years of age

• Documented diagnosis or r/o of ATTR amyloidosis

Locations
Other Locations
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Contact Information
Primary
Yen-Wen Wu
wuyw0502@gmail.com
886-2-8966-7000
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1000
Sponsors
Leads: Far Eastern Memorial Hospital

This content was sourced from clinicaltrials.gov