Periodic Reporting for period 2 - MPIPETrace (Clinical performance validation of a novel biomarker for quantitative imaging of coronary artery disease.)
Reporting period: 2017-04-01 to 2019-03-31
Having met successfully the end-points of phase I clinical trials, namely safety and early elimination of the injected dose of [11C] DMDPA in young healthy male adults, we proceeded in conducting phase II clinical trial.
The main objectives of phase II clinical trial were to assess the safety of [11C] DMDPA in subjects with known or suspected CAD (Coronary Artery Disease) and to optimize the dose levels for injection at vasodilatation stress and at rest.
With no patient withdrawal and no SAEs (serious adverse events) reported coupled with optimizing dose levels for injection, the main objectives of the study were achieved.
As secondary end-points of the trial the evaluation and optimization of image parameters and diagnostic ability were defined.
With defect magnitude evidenced coupled with the ability to diagnose perfusion disturbances and quantitatively assessing myocardial perfusion, the secondary objectives of the study were met.
In conclusion, study results show that the injected dose levels of [11C] DMDPA tested in patients with known or suspected CAD were safe and well tolerated. Optimized dose levels were defined and diagnostic ability was manifested thus [11C] DMDPA is a relevant candidate for MPI.
In the backdrop of the world ageing population, especially in Europe, we intend to contribute to the sustainability and equity of European health. The main two areas of contribution are decreasing the current number of annual deaths in Europe of 4 million and freeing related resources estimated today at EUR 200 M annually. Improving health and releasing resources will provide society at large more flexibility in deciding on social fund allocation and priorities.