Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
2 other identifiers
interventional
135
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 14, 2014
May 1, 2014
2.8 years
June 9, 2011
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being \>70% stenosis, on coronary CT angiography).
Up to 2 days
Secondary Outcomes (4)
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
Study Arms (1)
Single arm
OTHERThis is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard. All the patients will undergo the three imaging protocols.
Interventions
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
Maximum dose allowed per injection: 1000 MBq Intravenous Use
Eligibility Criteria
You may qualify if:
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
You may not qualify if:
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College Hospital London NHS Foundation Trust
London, London, NW1 2BU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Menezes, Dr.
University College Hospital London NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 23, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 14, 2014
Record last verified: 2014-05