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NCT04899180CompletedEarly phase 1

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study

Source: ClinicalTrials.gov · Last updated 7 Aug 2024

Brief summary (registry, in English)

The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
4 (actual)
First submitted
19 May 2021
Start date
14 Jul 2023
Primary completion date
5 Jan 2024
Lead sponsor
Mayo Clinic
Diseases
Amyloidosis
NCT number
NCT04899180

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 4
  • From 14 Jul 2023 to the primary completion date, 5 Jan 2024
  • 1 site in 1 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.

Prior treatment

  • Prior or current exposure to Plaquenil (Hydroxychloroquine)

Other illness

  • Any cardiac surgery or major chest trauma within 4 weeks of PYP scan
  • Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins. (Note that chronic troponin elevation is extremely common in cardiac amyloidosis).

Who the study is looking for

  • Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
  • Age ≥ 75 years
  • Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:
    • Moderate AS: 1.0 cm2 \< aortic valve area (AVA) ≤ 1.5 cm2
    • Severe AS: AVA ≤ 1.0 cm2

Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

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