Radioisotope Scintigraphy to Establish Incidence of Cardiac Amyloidosis Among Patients With Other… (NCT03098901) | Clinical Trial Compass
UnknownNot Applicable
Radioisotope Scintigraphy to Establish Incidence of Cardiac Amyloidosis Among Patients With Otherwise Unexplained Cardiac Disease
100 participantsStarted 2017-04-15
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Heart Failure with Preserved Ejection Fraction not explained by either hypertension or any other clinical condition.
✓. Systolic dysfunction and non-significant coronary artery disease.
✓. Diabetic cardiomyopathy
✓. Otherwise unexplained left ventricular hypertrophy (LVH).
✓. Under age of 65 and idiopathic ventricular fibrillation (VF) or multiple ventricular premature beats (VPB) or ventricular tachycardia (VT) with a structurally normal heart.
✓. Under age of 65, and unexplained sinus node disease, sinoatrial block, complete or high-degree atrio-ventricular block or significant intraventricular conduction defect, with structurally normal heart whether having or not having received permanent implanted pacemaker.
Exclusion criteria
✕. Primary amyloidosis cannot be excluded,
✕. Acute or recent (3 months) myocardial infarction,
✕
What they're measuring
1
diagnosis or exclusion of any type of cardiac amyloidosis;
Timeframe: immediately at the Tc99m scan performing or within a year form beginning of the recruitment