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Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00785564
First received: November 3, 2008
Last updated: November 4, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition
Sick Sinus Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Cardiac Electrical Remodeling With ECGI

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • ECGI Image [ Time Frame: 1 month after RV pacing ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of a pacemaker clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785564

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mitchell N Faddis, MD PhD     314-454-7772     mfaddis@wustl.edu    
Contact: Yvonne Oconnell     314-454-7851     yoconnel@im.wustl.edu    
Principal Investigator: Mitchell N Faddis, MD PhD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mitchell N Faddis, MD PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Mitchell N. Faddis MD, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00785564     History of Changes
Other Study ID Numbers: 07-0995
Study First Received: November 3, 2008
Last Updated: November 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
T-wave memory
Sick Sinus Syndrome

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013