Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-12

Study Completion Date

2020-09-30

Brief Summary

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Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.

This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.

Detailed Description

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Study procedures:

The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.

This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.

Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.

Conditions

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Atrial Fibrillation

Keywords

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microRNA biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery patients

The study cohort will comprise of patients without a history of AF that undergo cardiac surgery (CABG or mitral valve surgery) with increased CHADSVASC scores of ≥2.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery
* CHA2DS2 VASC score ≥ 2
* Sinus rhythm
* Age between 18 and 80 years
* Legally competent and willing and able to sign informed consent

Exclusion Criteria

* Unable or unwilling to comply with study procedures
* Documented or reported history of atrial fibrillation, atrial flutter (duration \> 5 minutes) or ventricular tachycardia
* Emergency or redo of CABG
* Emergency valvular surgery or pericarditis or endocarditis
* NYHA class IV heart failure symptoms or left ventricular ejection fraction \< 35%
* Pregnancy or of childbearing potential without adequate contraception
* History of previous radiation therapy of the thorax
* Active malignancy
* Active inflammtion or auto-immune disease
* Surgery for congenital anomalies
* Circumstances that prevent follow-up (no permanent home or address, transient, etc.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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J.R. de Groot

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joris de Groot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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van den Berg NWE, Neefs J, Kawasaki M, Nariswari FA, Wesselink R, Fabrizi B, Jongejan A, Klaver MN, Havenaar H, Hulsman EL, Wintgens LIS, Baalman SWE, Meulendijks ER, van Boven WJ, de Jong JSSG, van Putte BP, Driessen AHG, Boersma LVA, de Groot JR; PREDICT-AF Investigators. Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial. Heart Rhythm. 2021 Dec;18(12):2115-2125. doi: 10.1016/j.hrthm.2021.07.059. Epub 2021 Jul 29.

Reference Type DERIVED

PMID: 34332113 (View on PubMed)

van den Berg NWE, Neefs J, Berger WR, Boersma LVA, van Boven WJ, van Putte BP, Kaya A, Kawasaki M, Driessen AHG, de Groot JR; PREDICT AF Investigators. PREventive left atrial appenDage resection for the predICtion of fuTure atrial fibrillation: design of the PREDICT AF study. J Cardiovasc Med (Hagerstown). 2019 Nov;20(11):752-761. doi: 10.2459/JCM.0000000000000868.