None listed
Conditions
Brief summary
Patients with cardiac amyloidosis are known to have conduction disease, however, conduction disease is usually only identified once patients have developed overt heart failure. There is evidence to suggest that conduction disease may precede overt cardiac amyloidosis, providing an opportunity for earlier diagnosis and treatment of this condition.
Interventions
Screening for cardiac amyloidosis which includes a 99m Technitium-labelled pyrophosphate (PYP) scan and assessed using the Perugini scale to establish a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM), serum free light chain assay and serum immunofixation to assess for potential amyloid light chain (AL) amyloidosis. The initial screening would be performed following pacemaker insertion, either as an inpatient during the index pacemaker admission or as an outpatient. These tests will
Screening for cardiac amyloidosis which includes a 99m Technitium-labelled pyrophosphate (PYP) scan and assessed using the Perugini scale to establish a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM), serum free light chain assay and serum immunofixation to assess for potential amyloid light chain (AL) amyloidosis. The initial screening would be performed following pacemaker insertion, either as an inpatient during the index pacemaker admission or as an outpatient. These tests will be ordered by a member of the research team/the treating cardiology team. The pyrophosphate scan will be performed by the Nuclear medicine department at Eastern Health. Only one pyrophosphate scan will be required and the duration of the scan is 2 hours. The pathology tests including serum free light chain assay and serum immunofixation will be taken via blood sample through Eastern Health pathology services. The pathology test will take 15 minutes to acquire and only be required once. all patients will undergo a transthoracic echocardiogram to assess for signs of heart failure and other features of cardiac amyloidosis including both ventricular and atrial strain. Transthoracic echocardiograms should be performed as part of the work up for all patients with conduction disease so do not represent an additional test. Transthoracic echocardiograms are non-invasive tests that do not cause any harm to the patient and do not have any side effects. They do have a 1-hour time commitment and are conducted at Box Hill hospital. In patients with no evidence of plasma cell dyscrasia but a non-diagnostic PYP scan, there is a potential for early diagnosis of ATTR-CM with a Perugini score of 1, cardiac MRI and/or cardiac biopsy would be required on a case-by-case basis to investigate for other signs of ATTR-CM. If a cardiac MRI is required, patients will usually need to wait for 6 weeks until after their cardiac electronic implantable device is placed to be able to have a cardiac MRI. The cardiac MRI would be conducted at the Victorian Heart Hospital as Eastern Health does not have a cardiac MRI. The Cardiac MRI will take around 1 hour to complete and be performed by a Cardiologist.
Sponsors
Box Hill Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 65 or older who have new conduction disease requiring the implantation of a pacemaker.
Exclusion criteria
– Known cardiac amyloidosis. – Patients with a clear alternative cause of conduction disease including other infiltrative cardiomyopathies, ischaemia or medication induced conduction disease. – Patients with life expectancy < 12 months or severe comorbidities where screening would not be beneficial for the individual.
Outcome results
None listed