Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— PREDICT-AF  

Official title:

PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130985
• Other study ID #: NL50754.018.14
• Status: Completed
• Start date: May 12, 2015
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	North-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quality of Life defined by 36-Item Short Form Health Survey questionnaire	The quality of life is measured by 36-Item Short Form Health Survey questionnaires.	at 6 months and 1 year follow-up