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PREDICT-AF: Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Completed
CT.gov ID
NCT03130985
Collaborator
(none)
150
Enrollment
1
Location
64.7
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation
    Actual Study Start Date :
    May 12, 2015
    Actual Primary Completion Date :
    Jul 6, 2020
    Actual Study Completion Date :
    Sep 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. incident Atrial Fibrillation [within 2 years after surgery]

      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).

    2. Postoperative Atrial Fibrillation [within the first 30 days after surgery]

      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.

    Secondary Outcome Measures

    1. Quality of Life defined by 36-Item Short Form Health Survey questionnaire [at 6 months and 1 year follow-up]

      The quality of life is measured by 36-Item Short Form Health Survey questionnaires.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Medical Center Amsterdam North-Holland Netherlands 1105AZ

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Joris de Groot, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    J.R. de Groot, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT03130985
    Other Study ID Numbers:
    • NL50754.018.14
    First Posted:
    Apr 27, 2017
    Last Update Posted:
    Nov 12, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by J.R. de Groot, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    microRNA
    biomarker
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Nov 12, 2020