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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03048097 |
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Date of registration:
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02/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82
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Scientific title:
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Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis |
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Date of first enrolment:
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February 1, 2017 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03048097 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward J Miller, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Symptoms
- Palpitations/presyncope/syncope
- Heart failure symptoms Signs
- Abnormal ECG or Holter
- RBBB, LBBB, LAFB
- Abnormal Q waves in =2 leads
- 1st degree AVB > 240 msec, 2nd/3rd deg. AVB
- Frequent PVCs
- VT (sustained/non-sustained)
- LVEF < 50%
- Cardiac Regional Wall Motion Abnormality
Exclusion Criteria:
- Low likelihood of CS/Other explanation for symptoms
- Inability to consent
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sarcoidosis
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Intervention(s)
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Diagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging
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Drug: Fluorodeoxyglucose
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Drug: Rubidium
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Primary Outcome(s)
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The extent of inflammation
[Time Frame: 120 minutes]
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Severity of myocardial inflammation
[Time Frame: 120 minutes]
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The extent of inflammation
[Time Frame: 90 minutes]
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Visual interpretation of FDG uptake
[Time Frame: 90 minutes]
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Severity of myocardial inflammation
[Time Frame: 90 minutes]
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Visual interpretation of FDG uptake
[Time Frame: 120 minutes]
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Secondary Outcome(s)
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The extent of inflammation
[Time Frame: 2 weeks after initial scan]
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Visual interpretation of FDG uptake
[Time Frame: 2 weeks after initial scan]
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Severity of myocardial inflammation
[Time Frame: 2 weeks after initial scan]
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Secondary ID(s)
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1512016912
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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