Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial

June 3, 2018 updated by: Yong Seog Oh
Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

358

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Seo Ch-gu
      • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are scheduled to rhythm control of persistent atrial fibrillation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of erectile function
Time Frame: 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.
Erectile dysfunction 1 year after conversion to sinus rhythm.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of cognitive function
Time Frame: 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
cognitive dysfunction 1 year after conversion to sinus rhythm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Seog Oh

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 5, 2014

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 3, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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