- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785564
Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
January 4, 2019 updated by: Washington University School of Medicine
Imaging Cardiac Electrical Remodeling With ECGI
A consequence of chronic RV pacing is a process of electrical remodeling that alters myocardial repolarization to reflect the altered depolarization induced by the RV lead.
When RV pacing is discontinued, the altered repolarization persists for several weeks.
This phenomena is traditionally described as "T-wave memory" based upon the 12-lead ECG appearance of inverted T-Waves.
The investigators are using the ECGI technique to produce three dimensional electroanatomical images of this phenomena in patients with dual chamber pacemakers.
Echocardiography will also be used to image the mechanical effects of RV pacing and T-wave memory.
The images will show the spatial distribution of altered repolarization and allow us to correlate any mechanical consequences of this phenomena that may exist.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients of a pacemaker clinic
Description
Inclusion Criteria:
- Implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block.
Exclusion Criteria:
- Persistent atrial fibrillation that is not suppressed by medications.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ECGI Image
Time Frame: 1 month after RV pacing
|
1 month after RV pacing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mitchell N Faddis, MD PhD, Washington University School of Medicine
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
November 1, 2007
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
November 3, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (Estimate)
November 5, 2008
Study Record Updates
Last Update Posted (Actual)
January 8, 2019
Last Update Submitted That Met QC Criteria
January 4, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0995
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.