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Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients

Sponsor
Pusan National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475860
Collaborator
(none)
100
Enrollment
1
Location
24.2
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).

Condition or Disease Intervention/Treatment Phase
  • Device: implantable cardiac electronic device recipients

Detailed Description

Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers
Anticipated Study Start Date :
Jul 24, 2022
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients receiving cardiac implantable electronic device

Patients receiving cardiac implantable electronic device for any clinical indication

Device: implantable cardiac electronic device recipients
implantable cardiac electronic device recipients for any clinical indication
Other Names:
  • pacemaker
  • implantable cardioverter-defibrillator
  • cardiac resynchronization therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The occurrence of atrial high rate episode [12 months]

    Secondary Outcome Measures

    1. Factors predicting the occurrence of atrial high rate episode [12 months]

      factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients receiving cardiac implantable electronic device
    Exclusion Criteria:

    • patients who disagree for blood sampling to analyze not commonly used clinical biomarkers

    • patients not followed-up at least 12 months after implanting device

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinhee Ahn Busan Korea, Republic of

    Sponsors and Collaborators

    • Pusan National University Hospital

    Investigators

    • Principal Investigator: Jinhee Ahn, MD, Clinical associate professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jinhee Ahn, MD, Clinical associate professor, Pusan National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05475860
    Other Study ID Numbers:
    • H-1803
    First Posted:
    Jul 27, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Jul 27, 2022