Clinical Trial: Reappraisal of Atrial Fibrillation: RACE V - Work Package 5

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- Closing the Trans

Brief Summary:

In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of AF. Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.

For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.


Detailed Summary:

An estimated 380 patients will be included

Four patient categories will be included enabling to study patients with different stages of AF progression;

  1. Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
  2. Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
  3. Patients with self-terminating atrial fibrillation at inclusion, and
  4. Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.

Sponsor: Academisch Ziekenhuis Maastricht

Current Primary Outcome:

  • Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression [ Time Frame: 2.5 year follow up ]
  • Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression [ Time Frame: 2.5 year follow up ]
  • Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression [ Time Frame: 2.5 year follow up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • atrial fibrillation burden [ Time Frame: 2.5 year follow up ]
  • Number of atrial fibrillation episodes [ Time Frame: 2.5 year follow up ]
  • Duration of atrial fibrillation episodes [ Time Frame: 2.5 year follow up ]
  • Major adverse cardiovascular and cerebrovascular events (i.e. death, stroke, myocardial infarction) [ Time Frame: 2.5 year follow up ]
  • First recurrent atrial fibrillation; [ Time Frame: 2.5 year follow up ]
  • Self-terminating atrial fibrillation turning into non-self-terminating atrial fibrillation measured from ECGs and implantable loop recorders [ Time Frame: 2.5 year follow up ]
  • Electrical atrial fibrillation complexity or signs of atrial conduction disturbances measured from ECGs [ Time Frame: 2.5 year follow up ]


Original Secondary Outcome: Same as current

Information By: Academisch Ziekenhuis Maastricht

Dates:
Date Received: November 1, 2016
Date Started: November 2016
Date Completion: October 2021
Last Updated: April 18, 2017
Last Verified: April 2017