Validation of Different Diagnostic Modalities in the Detection of Cardiac Amyloidosis Among Patients With "Red Flags"

NCT06175858 | Not Yet Recruiting

• 1 other identifier: cardiac amyloidosis
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Validation of different diagnostic modalities in the detection of cardiac amyloidosis among patients with "red flags"

  • Detect the diagnostic yield of different diagnostic modalities for detection of cardiac amyloidosis and compare them.

  Baseline

Secondary Outcomes (1)

• 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

Study Arms (1)

Population with echocardiographic or clinical red flags for cardiac amyloidosis

OTHER

The study aims at including all population with the previously described red flags

Diagnostic Test: CMR

Interventions

CMR DIAGNOSTIC_TEST

We will use cmr and bone scintigraphy to detect cardiac amyloidosis due t the high accuracy and reliability

Also known as: BONE SCINTIGRAPHY

Population with echocardiographic or clinical red flags for cardiac amyloidosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• "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.

You may not qualify if:

• \- 1. Patient who refuse to give a consent to the following investigations. 2. 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

Alsayed ahmed

CONTACT

01127450433; sayedkelany20@gmail.com

hossam elaraby

CONTACT

01223971327; hosam_hasan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 19, 2023

Record last verified: 2023-12