Actively Recruiting

Age: 20Years +
All Genders
ID05593679

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

Led by Far Eastern Memorial Hospital · Updated on 2024-07-29

1000

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cardiac amyloidosis (CA) involves amyloid deposits in the heart, mainly caused by immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). This study focuses on patients in Taiwan, where the common ATTR mutation A97S is linked to left ventricular hypertrophy. Early diagnosis and proper treatment are crucial for better outcomes. The trial aims to improve diagnosis and prognosis by analyzing clinical and imaging data, using artificial intelligence to develop predictive models from 99mTc-PYP scans. Participants suspected or diagnosed with CA will undergo Tc-99m PYP cardiac scans to detect amyloid deposits. The study collects retrospective and prospective data from multiple medical centers in Taiwan, including imaging quality assessments and visual grading by nuclear medicine physicians. Genetic testing and blood and urine tests for AL amyloidosis will be performed when indicated. Follow-up for at least one year will monitor outcomes. Participants will provide clinical data and undergo imaging assessments, including PYP scans graded for amyloid uptake. Researchers will analyze these along with genetic and laboratory tests to build diagnostic and prognostic models. The primary outcome is death within one year, with secondary outcomes including cardiovascular death and hospitalization for heart failure. This observational study helps gather real-world evidence to guide clinical decisions and patient care over the study period.

CONDITIONS

Brief Title

A Multi-center Cardiac PYP Scan Registry in Taiwan

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 20 years of age or older
  • Documented diagnosis or suspicion of ATTR amyloidosis
Not Eligible

You will not qualify if you...

  • Pregnant or nursing (lactating) women
  • Important systemic diseases (except heart or neurological diseases) such as liver cirrhosis or active malignant tumors with life expectancy less than 6 months
  • Patients who refuse clinical follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Occurs at enrollment

Participants undergo Tc-99m PYP cardiac scans to assess myocardial uptake and image quality, which helps in diagnosing cardiac amyloidosis.

1 visit (in-person)

Long-term Monitoring

Duration - At least 1 year

Participants are followed for at least 1 year to monitor clinical outcomes including survival and hospitalizations.

Follow-up visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220

Actively Recruiting

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Research Team

Y

Yen-Wen Wu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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