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NCT06175858Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
22 Nov 2023
Start date
Jan 2024
Primary completion date
Oct 2026
Lead sponsor
Assiut University
Diseases
Amyloidosis
NCT number
NCT06175858

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From Jan 2024 to the primary completion date, Oct 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • \- 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.
  • 3\. Patient with established diagnosis of other infiltrative cardiac disease.

Who the study is looking for

  • "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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.