Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison

Study Overview
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Brief Summary
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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).

Official Title
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Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Rubidium-82
* Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>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. | Drug: Rubidium-82<br>* Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use<br>* Other names: CardioGen-82;Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)<br>* Maximum dose allowed per injection: 1000 MBq Intravenous Use<br>* Other names: Technescan MIBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium