Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison | Completed
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
Health Conditions
  • Coronary Artery Disease
Completed
Recruitment Status
NCT01379677
Primary Trial ID Number
Summary
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).
Primary Outcome Measures
  • The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography); Up to 2 days
Secondary Outcome Measures
  • Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.; Up to 2 days; Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.; Up to 2 days
Research Question
  • 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).
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
40 Years to N/A
Participant Type
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Trial Sample Size
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Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; Rubidium-82; Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use; [Single arm]; Drug; Sestamibi. reconstitution with sodium pertechnetate (99mTc); Maximum dose allowed per injection: 1000 MBq Intravenous Use; [Single arm]
Design Details
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Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Results Reporting
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Acronym
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Scientific Title
Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
Secondary Trial Identifying Number
2009-016645-25
Website
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Study Funded By
Advanced Accelerator Applications
Funder Type
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Study Sponsored By
Advanced Accelerator Applications
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

09 Jun 2011

Last Updated

13 May 2014

Date Record Refreshed on UKCTG

31 Jul 2015