Validation of Different Diagnostic Modalities in the Detection of Cardiac Amyloidosis Among Patients With "Red Flags"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Primary Endpoint
- Validation of different diagnostic modalities in the detection of cardiac amyloidosis among patients with "red flags"
Study Overview
Brief Summary
The study aims to test and compare the diagnostic yield of different diagnostic modalities (speckle tracking echocardiography, CMR, serum and urine protein analysis and bone tracer scintigraphy) in the detection of cardiac amyloidosis among patients with "red flags" suspecting cardiac amyloidosis.
Detailed Description
Cardiac amyloidosis (CA) is a condition that can be caused by rare genetic variants in the hereditary forms or because of acquired conditions. It is one of the serious and progressive infiltrative disease that is caused by the deposition of amyloid fibrils at the cardiac level .
Cardiac amyloidosis causes restrictive cardiomyopathy, and this is caused by extracellular deposition of proteins in the myocardium. The proteins have an unstable structure that causes them to misfold, aggregate, and deposit as amyloid fibrils .
According to the nature of the infiltrating protein, cardiac amyloidosis has two main subtypes, immunoglobulin light chain cardiac amyloidosis (AL-CA), and transthyretin cardiac amyloidosis (ATTR-CA) which is further subdivided according to the presence or absence of a mutation in the transthyretin gene into wild-type (ATTRwt-CA) and variant (ATTRv-CA) .
Despite of being one of the most serious, fetal diseases, and a considerable cause of heart failure with preserved ejection fraction (HFpEF), cardiac amyloidosis is still significantly underdiagnosed, this may be due to its varied presentations and lack of awareness about the nature of the disease. Awareness of "red flags" suggestive of amyloidosis can enhance one's index of appropriate clinical suspicion and enable earlier diagnosis of CA .
Diagnosis of CA:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •"Red flags" include any one of the following:
- •Clinical "Red flags":
- •Bilateral carpal tunnel syndrome (30).
- •"Popeye sign", rupture of long head of the biceps tendon.
- •Lumbar spinal canal stenosis in association with unilateral carpal tunnel syndrome (31).
- •Echocardiographic/imaging "Red Flags"
- •LV wall thickness ≥ 12 mm and heart failure in men > 60 y/ women > 70y.
- •LV wall thickness ≥ 12 mm and AV-Block or pacemaker.
- •Infiltrative phenotype (biventricular hypertrophy, thickening of cardiac valves, pericardial effusion, thickening of the interatrial septum).
- •LV wall thickness ≥ 12 mm and low voltage on ECG.
- •Paradoxical low flow/low gradient aortic stenosis.
Exclusion Criteria
- •Patient who refuse to give a consent to the following investigations.
- •Patient with any contra-indication to undergo CMR, or bone scintigraphy will be excluded e.g., non compatible implantable cardiac devices, claustrophobic, severe kidney function impairment.
- •Patient with established diagnosis of other infiltrative cardiac disease.
Arms & Interventions
Population with echocardiographic or clinical red flags for cardiac amyloidosis
The study aims at including all population with the previously described red flags
Intervention: CMR (Diagnostic Test)
Outcomes
Primary Outcomes
Validation of different diagnostic modalities in the detection of cardiac amyloidosis among patients with "red flags"
Time Frame: Baseline
• Detect the diagnostic yield of different diagnostic modalities for detection of cardiac amyloidosis and compare them.
Secondary Outcomes
- i. Identification of the percentage of patients who will have a final confirmed diagnosis of cardiac amyloidosis among all included patients with "red flags".(Baseline)
Investigators
Alsayed Ali Mahmoud Ahmed
Resident
Assiut University