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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
Sponsor:
Information provided by (Responsible Party):
Sara Shimoni, Kaplan Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiac TTR Amyloidosis Diagnostic Test: Tc99m-labeled pyrophosphate scan Not Applicable

  Show Detailed Description

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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

  1. Patients suffering of HFpEF not explained by either hypertension or any other clinical condition.
  2. Patients with systolic dysfunction and non-significant coronary artery disease.
  3. Patients with diabetic cardiomyopathy
  4. Patients with otherwise unexplained left ventricular hypertrophy (LVH).
  5. Patients under age of 65 with idiopathic ventricular fibrillation (VF) or multiple ventricular premature beats (VPB) or ventricular tachycardia (VT) with a structurally normal heart.
  6. Patients under age of 65, with 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Heart Failure with Preserved Ejection Fraction not explained by either hypertension or any other clinical condition.
  2. Systolic dysfunction and non-significant coronary artery disease.
  3. Diabetic cardiomyopathy
  4. Otherwise unexplained left ventricular hypertrophy (LVH).
  5. Under age of 65 and idiopathic ventricular fibrillation (VF) or multiple ventricular premature beats (VPB) or ventricular tachycardia (VT) with a structurally normal heart.
  6. 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:

  1. Primary amyloidosis cannot be excluded,
  2. Acute or recent (3 months) myocardial infarction,
  3. Acute or recent (12 months) myocarditis,
  4. Oncologic or any other co-morbidity, which can shorten the patient's survival to less than one year,
  5. End stage renal disease treated with dialysis,
  6. Ischemic cardiomyopathy,
  7. Non-TTR amyloidosis known or suspected,
  8. Another type of cardiomyopathy (for ex. arrhythmogenic right ventricular dysplasia),
  9. Any disease or clinical condition that can lead to cardiomyopathy (history of anthracyclines treatment, history of alcohol abuse, multiple myeloma, sarcoidosis, carcinoid, inflammatory and autoimmune diseases).

Publications:

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Responsible Party: Sara Shimoni, Dr Sara Shimoni, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT03098901     History of Changes
Other Study ID Numbers: KMC-0018-17
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Shimoni, Kaplan Medical Center:
TTR Amyloidosis
Heart Failure with Preserved Ejection Fraction
Ventricular arrhythmia
Cardiac Conduction Disturbances

Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases