Eliminating Uncertainty in Coronary Artery Disease

Informations projet

EU-CAD

N° de convention de subvention: 960899

DOI

10.3030/960899

Projet clôturé

Date de signature de la CE 19 Août 2020

Date de début 1 Août 2020

Date de fin 31 Juillet 2022

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 3 572 775,00

Contribution de l’UE

€ 2 500 000,00

Coordonné par

MEDTRACE PHARMA A/S
Denmark

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Demonstrators, pilots, prototypes (1)

2.2 Code and Infrastructure Validation

Based on Deliverable 2.2. the new aQuant code and infrastructure will be tested at selected hospitals in Europe and validated according to EU regulatory standards as well as operational specifications defined in deliverable 2.1.

Documents, reports (2)

3.2 Regulatory Approval EU

Founded on deliverable 31 the subsequent focus is to apply for and achieve regulatory approval for the MedTrace solution in the EU in the form a CEmark as medical device of the software and the medical device part of the hardware

3.1 Clinical Study EU

"In order to approve the MedTrace solution as medical device, the company needs to carry out a minor clinical study using 15O-water in cardiac patients to prove safety and efficacy. Part of this study is to purchase already existing data from Amsterdam University Medical Centers from a recent similar clinical trial. In parallel the clinical study will be prepared (study protocol, site recruitment, clinical trial agreements and patient recruitment) End deliverable is ""last patient scanned""."

Publications

Other (3)

Initial Experience with routine 15O-water cardiac PET workflow

Auteurs: Susanne Hansen, Jeppe Madsen, Shakti Nicolai Johansen, Charlotte Jensen, Lone Winkler, Lars Gormsen and Lars Tolbod, ,
Publié dans: Journal of Nuclear Medicine, Numéro May 2021, 62 (supplement 1), 2021, Page(s) 3001, ISSN 2047-2412
Éditeur: SNM

Cardiac viability PET using combined parametric 15O-water blood flow/18F-FDG metabolism compares well with 82Rb/18F-FDG

Auteurs: Mette Kjaerulff, Simon Madsen, Kirsten Bouchelouche, Lars Gormsen and Lars Tolbod
Publié dans: Journal of Nuclear Medicine, Numéro May 2021, 62 (supplement 1), 2021, Page(s) 1632
Éditeur: SNMMI

Routine clinical use of 15O-water cardiac PET: Initial experience with a novel automated solution

Auteurs: LP Tolbod, LC Gormsen
Publié dans: European Heart Journal - Cardiovascular Imaging, Numéro Volume 22, Numéro Supplement_3, June 2021, 2021
Éditeur: European Society of Cardiology
DOI: 10.1093/ehjci/jeab111.029