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Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial

Sponsor
Yong Seog Oh (Other)
Overall Status
Unknown status
CT.gov ID
NCT02742896
Collaborator
(none)
358
Enrollment
1
Location
70
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Condition or Disease Intervention/Treatment Phase
  • Other: Erectile dysfunction

Detailed Description

Sinus conversion by electrical cardioversion increase cardiac output and systemic perfusion. According to recent reports, maintenance of sinus rhythm increase systemic perfusion which leads to improve renal function. Therefore, we hypothesized that sinus conversion of patients with atrial fibrillation will increase systemic perfusion which might improve the erectile dysfunction and cognitive dysfunction.

Study Design

Study Type:
Observational
Anticipated Enrollment :
358 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
Study Start Date :
Dec 1, 2013
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Restoration of Erectile dysfunction

The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.

Other: Erectile dysfunction
The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm. The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm.
Other Names:
  • official questionnaire

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The changes of erectile function [Erectile dysfunction 1 year after conversion to sinus rhythm.]

      The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.

    Secondary Outcome Measures

    1. The changes of cognitive function [cognitive dysfunction 1 year after conversion to sinus rhythm]

      The changes of cognitive function by using validated assessment form-The Montreal Cognitive Assessement(MoCA) 1 year after conversion to sinus rhythm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients scheduled to electrical cardioversion
    Exclusion Criteria:

    • Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.

    • More than moderate degree of cognitive dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul St Mary's Hospital Seoul Seo Ch-gu Korea, Republic of 137-701

    Sponsors and Collaborators

    • Yong Seog Oh

    Investigators

    • Principal Investigator: Yong Seog Oh, MD, Seoul St Mary hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yong Seog Oh, professor, Seoul St. Mary's Hospital
    ClinicalTrials.gov Identifier:
    NCT02742896
    Other Study ID Numbers:
    • ERECT
    First Posted:
    Apr 19, 2016
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Yong Seog Oh, professor, Seoul St. Mary's Hospital
    Erectile dysfunction
    cognitive function
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jun 6, 2018