Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation (RACE V)

Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation

The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam University Medical Center - AMC
  • Amsterdam, Netherlands
    • Amsterdam University Medical Center - VU
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Groningen, Netherlands, 9728 NT
    • Martini Hospital
  • Groningen, Netherlands
    • Ommelander Ziekenhuis
  • Roermond, Netherlands
    • Laurentius Hospital
  • Zwolle, Netherlands
    • Isala
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Rijnstate Hospital
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with paroxysmal (self-terminating) AF in the cardiology outpatient department, first (heart) aid and pacemaker clinic.

Description

Inclusion Criteria:

• New onset or history of paroxysmal, self-terminating AF documented as:

  • AF on ECG or Holter-recording or loop recorder
  • Subclinical AF detected in implantable cardiac devices (atrial read > 190 beats per minute, lasting > 6 minutes).
• Prior history of self-terminating AF is allowed;
• Able and willing to sign informed consent for the registry;
• Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);

• In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):

  • CHA2DS2-VASc score ≤5 (history of Congestive heart failure, Hypertension, Age ≥ 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex);
  • No other indication for oral anticoagulation (e.g. mechanical valve prosthesis);
  • Patient is willing to temporarily stop oral anticoagulation drugs (OAC).

Exclusion Criteria:

• Non-self-terminating, persistent AF;
• Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
• Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);
• On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;
• Expected to start with amiodarone;
• Pregnancy;
• Life expectancy of less than 2.5 years.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression of AF burden	2.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Cardiac and Cerebrovascular Events	2.5 years
Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system	2.5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Maastricht University Medical Center
• Investigators: Principal Investigator: Harry JGM Crijns, MD, PhD, Maastricht University Medical Center; Principal Investigator: Isabelle C Van gelder, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• Nguyen BO, Weberndorfer V, Crijns HJ, Geelhoed B, Ten Cate H, Spronk H, Kroon A, De With R, Al-Jazairi M, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, Luermans J, de Groot J, Allaart CP, Elvan A, De Melis M, Scheerder C, van Zonneveld AJ, Schotten U, Linz D, Van Gelder I, Rienstra M. Prevalence and determinants of atrial fibrillation progression in paroxysmal atrial fibrillation. Heart. 2022 Jul 20;109(3):186-94. doi: 10.1136/heartjnl-2022-321027. Online ahead of print.
• De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, Jan van Zonneveld A, Erkuner O, Bayon MA, Schmidt AS, Luermans JGLM, Crijns HJGM, Van Gelder IC, Rienstra M. Different circulating biomarkers in women and men with paroxysmal atrial fibrillation: results from the AF-RISK and RACE V studies. Europace. 2022 Feb 2;24(2):193-201. doi: 10.1093/europace/euab179.
• De With RR, Erkuner O, Rienstra M, Nguyen BO, Korver FWJ, Linz D, Cate Ten H, Spronk H, Kroon AA, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, de Groot JR, Elvan A, de Melis M, Scheerder COS, Al-Jazairi MIH, Schotten U, Luermans JGLM, Crijns HJGM, Van Gelder IC; RACE V Investigators. Temporal patterns and short-term progression of paroxysmal atrial fibrillation: data from RACE V. Europace. 2020 Aug 1;22(8):1162-1172. doi: 10.1093/europace/euaa123.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimated): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Arrhythmias, Cardiac; Hematologic Diseases; Atrial Fibrillation; Thrombophilia; Atrial Remodeling
• Other Study ID Numbers: NL53561.042.16