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.
Conditions
Interventions
Trade Name: CardioGen-82
Product Name: CardioGen-82
Pharmaceutical Form: Radionuclide generator
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: RUBIDIUM (82 RB)
Sponsors
Advanced Accelerator Applications
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Referred for scintigraphy to assess myocardial ischaemia. - Ability to give informed written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: - Impaired capacity to consent - Pregnancy, or breastfeeding - Allergy to iv contrast - Renal failure - Severe, uncontrolled asthma - Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare PET vs SPET, with the primary outcome being the sensitivity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography).;Secondary Objective: The secondary objectives are to evaluate the performance of Rubidium-82 as compared to Tc-99m-MIBI, in terms of clinical interpretation, per-cent myocardium that is hypoperfused, artefacts and image quality and determine patient tolerance with each technique.;Primary end point(s): The primary outcome is to assess the efficacy of PET versus SPET. This will be assessed by using a diagnostic decision matrix (Specificity, True Positive, True Negative, False Positive, False Negative) and coronary CT angiography is used as the reference standard.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of primary and secondary endpoints is Day 1 (or at Day 2 according to patient BMI-determined Technetium-99m-MIBI myocardial perfusion imaging protocol). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
United Kingdom
Contacts
Public ContactPaola Santoro
Advanced Accelerator Applications
Outcome results
None listed