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Research Question
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The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82
PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).
(from ClinicalTrials.gov)
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Ethics Approval
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Sorry, not currently available
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Study Design
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Coronary Artery Disease
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Participants Inclusion Criteria
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Inclusion Criteria:
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
Exclusion Criteria:
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
- Claustrophobia
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Participants Exclusion Criteria
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Inclusion Criteria:
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
Exclusion Criteria:
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
- Claustrophobia
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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135
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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London
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Interventions
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Drug; Rubidium-82; Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use; Single arm; CardioGen-82; Drug; Sestamibi. reconstitution with sodium pertechnetate (99mTc); Maximum dose allowed per injection: 1000 MBq Intravenous Use; Single arm; Technescan MIBI
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Primary Outcome Measures
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The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
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Secondary Outcome Measures
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Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.; Up to 2 days; No; Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; No; Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; No; Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.; Up to 2 days; Yes
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Website
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Sorry, not currently available
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