Radioisotope Scintigraphy to Establish Incidence of Cardiac Amyloidosis Among Patients With Otherwise Unexplained Cardiac Disease
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|ClinicalTrials.gov Identifier: NCT03098901|
Recruitment Status : Unknown
Verified April 2017 by Sara Shimoni, Kaplan Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac TTR Amyloidosis||Diagnostic Test: Tc99m-labeled pyrophosphate scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Patients that suffer of one of the following conditions will be included in the study
|Masking:||None (Open Label)|
|Official Title:||Tc99m-PYP Scintigraphy in Order to Establish Incidence of Cardiac Transthyretin Amyloidosis Among Patients With Otherwise Unexplained Cardiomyopathies|
|Estimated Study Start Date :||April 15, 2017|
|Estimated Primary Completion Date :||April 15, 2018|
|Estimated Study Completion Date :||April 15, 2018|
|no other arm||
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).
- diagnosis or exclusion of any type of cardiac amyloidosis; [ Time Frame: immediately at the Tc99m scan performing or within a year form beginning of the recruitment ]diagnosis of cardiac TTR amyloidosis, or any other type of cardiac amyloidosis, or diagnosis of another condition other than amyloidosis explaining the patient's clinical cardiological findings