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99mTc-PYP Scan for Aortic Stenosis
Phase < 1
Recruiting
Led By Omar F Abou Ezzeddine, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 75 years
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial is testing a new way to detect a heart condition called transthyretin cardiac amyloidosis (TTR-CA) in people with aortic stenosis.
Who is the study for?
This trial is for people aged 75 or older living in Southeast Minnesota with moderate to severe aortic stenosis, which means their heart's aortic valve opening is smaller than normal. They can't have had recent heart surgery, major chest trauma, or a heart attack within the last month and should not have taken the drug Plaquenil.Check my eligibility
What is being tested?
The study aims to find out how common transthyretin cardiac amyloidosis (a type of heart disease where abnormal proteins build up) is among those with narrowed heart valves. It uses a special imaging test called 99mTc-PYP SPECT/CT to detect this condition.See study design
What are the potential side effects?
While specific side effects are not listed for this diagnostic procedure, generally such scans may cause discomfort at injection site, allergic reactions to the tracer substance used, and exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 75 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of TTR-CA in patients with moderate and severe aortic stenosis
Trial Design
1Treatment groups
Experimental Treatment
Group I: SPECT/CTExperimental Treatment1 Intervention
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
99mTc-PYP
2017
Completed Early Phase 1
~290
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,773,209 Total Patients Enrolled
Omar F Abou Ezzeddine, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe aortic stenosis with a valve area of 1.0 cm2 or less.You have been diagnosed with moderate or severe aortic stenosis based on a recent echocardiogram within the last 6 months.You live in one of these counties in Southeastern Minnesota: Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele.I had a heart attack within the last month confirmed by tests.Your aortic valve area is between 1.0 cm2 and 1.5 cm2.I have not had heart surgery or major chest injuries in the last 4 weeks.I am 75 years old or older.I have taken Plaquenil before.
Research Study Groups:
This trial has the following groups:- Group 1: SPECT/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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