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Radioisotope Scintigraphy to Establish Incidence of Cardiac Amyloidosis Among Patients With Otherwise Unexplained Cardiac Disease

NCT03098901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-05

No results posted yet for this study

Summary

Cardiac amyloidosis is a multi-organ syndrome, which usually presents as restrictive cardiomyopathy (RCM). Transthyretin (TTR) amyloidosis (or ATTR) is a subtype of amyloidosis which frequently involves heart. Cardiac ATTR, though infrequently diagnosed during lifetime, may represent a prevalent cause of RCM, especially in elderly. Several medications that can limit progression of the disease are currently under investigation. Presently the golden standard for diagnosis of ATTR is endomyocardial biopsy (EMB) which may entail severe adverse complications causing under-diagnosis of ATTR.

Several papers support the evidence that Tc99m-labeled tracers can be used to detect myocardial deposits of TTR amyloid. It was suggested that Tc99m scintigraphy might be a highly sensitive diagnostic tool for cardiac ATTR. In this study the patients with otherwise unexplained cardiomyopathy or heart block will undergo Tc99m scan, which will establish the incidence of this largely underdiagnosed condition in the population.

Conditions

  • Cardiac TTR Amyloidosis

Interventions

DIAGNOSTIC_TEST

Tc99m-labeled pyrophosphate scan

Intravenous injection of Tc99m-labeled pyrophosphate with consecutive whole body scan using gamma ray scanner for assessment of radioactive uptake in the heart. The results of the scan will be evaluated by a specialist in the field. The uptake will be graded using Perugini scale (0- no uptake, 1- uptake in heart less intense than in bones, 2-uptake in heart as intense as in bones, 3-uptake in heart more intense than in bones).

Sponsors & Collaborators

  • Kaplan Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2018-04-15
Completion
2018-04-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098901 on ClinicalTrials.gov