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NCT Number: NCT05593679

A Multi-center Cardiac PYP Scan Registry 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 20 years of age
  • Documented diagnosis or r/o of ATTR amyloidosis

Exclusion criteria

  • 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.

Treatment and study plan

Tc-99m PYP Cardiac scan

Diagnostic Test

Tc-99m PYP Cardiac scan

Primary outcomes

  1. Death

    Time frame: 1 year

    Death

Secondary outcomes

  1. CV death

    Time frame: 1 year

    CV death

  2. Hospitalization for heart failure

    Time frame: 1 year

    Hospitalization for heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Yen-Wen Wu

CONTACT

[email protected]

886-2-8966-7000 ext. 1090

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2022
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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