- Enrolment of a representative cross-section of AF patients in Europe.- Detailed analysis of clinical and relevant parameters (digitalised ECG, cardiac imaging, blood biomarkers) that could be used during clinical practise for the diagnosis of…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The general objectives of the MAESTRIA-AFNET 10 study on clinical epidemiology
and medical management of atrial fibrillation (AF) are summarized as follows:
- Enrolment of a representative cross-section of AF patients in Europe.
- Detailed analysis of clinical and relevant parameters (digitalised ECG,
cardiac imaging, blood biomarkers) that could be used during clinical practise
for the diagnosis of atrial cardiomyopathy and patient*s outcome.
- The data sets will be assessed using Artificial Intelligence (AI) algorithms
to characterise specific subgroups of AF or define novel outcome predictors.
Secondary outcome
Potential Outcome Parameters
* AA burden and vascular stiffness (measured by Preventicus Heartbeats and a
wearable with photoplethysmographic -PPG- sensor to be coupled
with a smartphone for continuous heart rhythm monitoring for 12 months).
* MoCA Cognitive function test.
* EQ-5D-5L Quality of Life questionnaire.
* Ischaemic events (systemic, myocardial and cerebral) at 12 months.
* Clinically relevant changes in CT/MRI for patients in which CT or MRI is
clinically indicated.
- ECG analysis
- All variables from ECGs, CTs, MRIs & echos will be integrated for final
assessment.
Background summary
Atrial fibrillation (AF) and stroke are major health care problems in Europe.
They are most often the clinical expression of atrial cardiomyopathy, which is
under-recognised due to the lack of specific diagnostic tools.
Multidisciplinary research and stratified approaches are urgently needed to
prevent, diagnose, and treat AF and stroke and preempt the AF-related threat to
healthy ageing in Europe.
MAESTRIA is a European consortium of 18 clinicians, scientists and pharma
industry partners who are at the forefront of research and medical care of AF
and stroke patients funded by the EU Horizon 2020 programme (grant number
965286). The Atrial Fibrillation Network (AFNET) is one of the 18 partner
institutions in this European consortium.
MAESTRIA will create multi-parametric digital tools based on a new generation
of biomarkers that integrate artificial intelligence (AI) processing and big
data from cutting edge imaging, electrocardiography and omics technologies. It
will develop novel biomarkers, diagnostic tools and personalized therapies for
atrial cardiomyopathy.
The MAESTRIA-AFNET 10 Study is an integral part of the MAESTRIA project.
The study will collect relevant clinical parameters for AF from patients, this
includes ECGs, cardiac CTs, MRIs and echocardiograms. Dedicated core labs will
collect and homogenize the clinical data.
For atrial arrhythmias (AA) and vascular stiffness index (VSI) recording,
patients will be provided with a measuring bracelet for continuous monitoring
of heart rhythm with a photoplethysmographic (PPG) sensor coupled with a
MAESTRIA_WP4 Study Protocol_final version 1.0_20220623 Page 10 of 52
smartphone app and the Preventicus Heartbeats® analytic service (Class IIa, CE
marked), approved as consumer device. Preventicus is ISO 13485 certified.
Study objective
- Enrolment of a representative cross-section of AF patients in Europe.
- Detailed analysis of clinical and relevant parameters (digitalised ECG,
cardiac imaging, blood biomarkers) that could be used during clinical practise
for the diagnosis of atrial cardiomyopathy and patient outcome. The data sets
will be assessed including but not limited to AI algorithms to
characterize specific subgroups of AF or define novel outcome predictors.
Study design
International, multi-centre, non-interventional, observational registry. All
patients will be treated in accordance to the current ESC AF Guidelines 2020.
Study burden and risks
As reported by patients such as side effects of the wearable
Mendelstraße 1 11
Münster 48149
NL
Mendelstraße 1 11
Münster 48149
NL
Listed location countries
Age
Inclusion criteria
1. Patients with paroxysmal AF (clinically defined as AF episodes less than one
week), or
patients with persistent AF (clinically defined as AF episodes longer than one
week),
or patients with permanent AF (no documented sinus rhythm or possibility to
restore sinus rhythm by any means).
2. Patient (or legally acceptable representative if applicable) provides
written Informed Consent to participate in the study. The patient has the
option to give separate consent to donate extra volume of blood during routine
blood collection, that can be used for biomedical research.
3. Patient is at least 18 years of age.
4. Patient must own a Smartphone with Apple iOS Version 14.5 (or higher) or
with Android Version 8.0 (or higher).
Exclusion criteria
1. Any disease that limits life expectancy to less than 1 year.
2. All persons unable to provide informed consent.
3. All persons exempt from participation in a study or trial by law.
4. Any medical or psychiatric condition which, in the Investigator*s opinion,
would preclude the participant from adhering to the protocol or completing the
study per protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | https://maestria-h2020.com/, https://www.ihuican.org. |
| CCMO | NL81963.068.23 |