Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
Overview
- Phase
- Phase 3
- Intervention
- Rubidium-82
- Conditions
- Coronary Artery Disease
- Sponsor
- Advanced Accelerator Applications
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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).
Investigators
Eligibility 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
Arms & Interventions
Single arm
This 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.
Intervention: Rubidium-82
Single arm
This 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.
Intervention: Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Outcomes
Primary Outcomes
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
Time Frame: Up to 2 days
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).
Secondary Outcomes
- Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.(Up to 2 days)
- 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)