Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation

NCT03130985 | Completed

• 1 other identifier: NL50754.018.14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

microRNA; biomarker

Outcome Measures

Primary Outcomes (2)

• incident Atrial Fibrillation

  A de novo 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode within 2 years after surgery (with a blanking period for the postoperative period \<30 days).

  within 2 years after surgery

• Postoperative Atrial Fibrillation

  A 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode in the first 30 days following cardiac surgery or registered at the first 24h Holter monitoring if scheduled within 6 weeks following cardiac surgery.

  within the first 30 days after surgery

Secondary Outcomes (1)

• Quality of Life defined by 36-Item Short Form Health Survey questionnaire

  at 6 months and 1 year follow-up

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients are eligible that are referred to the investigators' tertiary cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery bypass surgery and meet in- and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 34332113 DERIVED

• 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.

  PMID: 31567634 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Left atrial appendages will be deep frozen and fixed Plasma samples and whole blood will be collected

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joris de Groot, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: April 27, 2017
• Study Start: May 12, 2015
• Primary Completion: July 6, 2020
• Study Completion: September 30, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

NL (1)