NCT00745602

Brief Summary

The proposed research will investigate whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow. To further delineate this finding, investigation of these potential effects will include differences in postural positioning. This data will be used to further understand the overall hemodynamic effects of atrial fibrillation on extra-cardiac organs of the body.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

August 29, 2008

Last Update Submit

January 7, 2019

Conditions

Keywords

direct current cardioversion, cerebral blood flow

Outcome Measures

Primary Outcomes (1)

  • to determine whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow

    0

Study Arms (1)

1

EXPERIMENTAL

Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.

Procedure: non-invasive testing

Interventions

non-invasive tests including Transcranial Doppler ultrasound (TCD), manual cuff blood pressure (BP), beat to beat BP monitoring by a Portapress monitor, and respiratory tidal CO2

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with atrial fibrillation scheduled for DCCV
  • Subjects must be at least 18 years of age
  • Subjects must have the ability to understand and sign informed consent and be willing to comply with full testing and evaluation

You may not qualify if:

  • Subjects in sinus rhythm without assessment of any prior atrial fibrillation by this research team
  • Subjects unable to understand and given informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose A Joglar

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 3, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations