Cardiac AmyloidosisNCT04146415
Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
A study testing Spect scan with mTc99-PYP in people with Cardiac Amyloidosis, run by Tel-Aviv Sourasky Medical Center.
Trial summary
1. Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP. 2. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Spect scan with mTc99-PYP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
- Patients who performed will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera
Who cannot join
- 1.None
About this study
- Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP.
- On the day of the examination, the examiner will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Before conducting the test, the subject will undergo a brief interview by a physician, receive an explanation of the study and, if agreed, sign an agreement to perform a further examination on the CZT camera.
- The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of
- Conditions
- Cardiac Amyloidosis
- Being tested
- Spect scan with mTc99-PYP
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spect scan with mTc99-PYPDiagnostic test
. About forty-five minutes after the injection mTc99-PYP , flanner and SPECT-CT mappings will be performed and then the patient will move to the CZT camera and undergo another photograph.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac amyloidosis patients | Experimental | Not described Receives: Diagnostic Test: Spect scan with mTc99-PYP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.
Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146415
- Sponsor's protocol ID
- TASMC-18-ES-0042-CTIL
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
- ClinicalTrials.gov ID
- NCT04146415
- Acronym / sponsor ID
- TASMC-18-ES-0042-CTIL
- Conditions
- Cardiac Amyloidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP.
- On the day of the examination, the examiner will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Before conducting the test, the subject will undergo a brief interview by a physician, receive an explanation of the study and, if agreed, sign an agreement to perform a further examination on the CZT camera.
- The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac amyloidosis patients | Experimental | Diagnostic Test: Spect scan with mTc99-PYP |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
- Patients who performed will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera
Key exclusion criteria (1 listed)
- 1.None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spect scan with mTc99-PYP. About forty-five minutes after the injection mTc99-PYP , flanner and SPECT-CT mappings will be performed and then the patient will move to the CZT camera and undergo another photograph. | Diagnostic test | Cardiac amyloidosis patients |
Primary outcome
Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.
Time frame: 1 year
Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Amyloidosis
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingObservational study
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
Recruiting
Elevated Rate Pacing of Cardiac Amyloidosis
Cardiac Amyloidosis, Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spect scan with mTc99-PYP in people with Cardiac Amyloidosis, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who preformed mTc99-PYP for cardiac amyloidosis imaging. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.