The Use of CT to Identify Damaged Heart Muscle in Patients Undergoing Ventricular Tachycardia Ablation.

This study has been terminated.
(key study staff left foundation)
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583284
First received: December 20, 2007
Last updated: June 10, 2008
Last verified: June 2008
  Purpose

Patients with ventricular tachycardia (VT) undergo catheter ablation. During the ablation procedure, the heart is mapped to determine areas of heart muscle damage. The heart scarring areas are often the source of the VT. Delayed enhancement CT has recently been used to determine areas of scarring . This study is to determine if the areas of damaged heart muscle mapped with the delayed enhancement CT correlate with the same areas that are determined during the catheter ablation.


Condition
Ventricular Tachycardia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Utility of Delayed-Enhancement Multi-Detector Computed Tomography Imaging in Identifying Arrhymogenic Substrate in Patients Undergoing Catheter Ablation for Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Areas of hyperenhanced myocardium, as determined by delayed enhancement CT, correlate with the findings on voltage mapping of the LV in patients with a prior myocardial infarction who are undergoing VT ablation. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2006
Study Completion Date: March 2008
Detailed Description:

Catheter ablation of ventricular tachycardia (VT) is performed in patients who have recurrent VT despite the use of other therapies. Electroanatomic mapping of the left ventricular myocardium is performed as part of these procedures to define the arrhythmogenic substrate for subsequent ablation. We hypothesize that delayed enhancement multi-detector computed tomography (MDCT) will identify areas of myocardial scarring or fibrosis that correlate with findings of voltage mapping in patients with a prior myocardial infarction who are undergoing VT ablation. We will perform a pilot study involving 10 patients with coronary artery disease scheduled for VT ablation to determine the ability of delayed enhancement MDCT to identify arrhythmogenic substrates in these patients, when compared with electroanatomic mapping. All patients will undergo a standard of care 64-slice MDCT study, followed 5 minutes later by the research delayed enhancement acquisition. We will evaluate the relationship between hyperenhanced myocardium, as detected by delayed enhancement MDCT, and abnormal myocardium detected on voltage mapping, defined as areas of myocardium with < 0.5 mV signal amplitude. Studies will be performed on the new Siemens 64-slice dual source CT scanner, which reduces radiation exposure from the scan by 33-50%. This study will generate preliminary data which will be used for subsequent NIH/AHA grant applications or industry sponsored trials.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients coming to Cleveland Clinic for catheter ablation for ventricular tachycardia

Criteria

Inclusion Criteria:

  • Age > 21 years
  • Prior myocardial infarction
  • Scheduled for CT scan < 1 week prior to VT ablation for ventricular arrythmia

Exclusion Criteria:

  • Serum creatinine > 1.8 mg/dL
  • Contrast dye allergy
  • Atrial fibrillation
  • Unable to lie flat for the duration of image acquistion (15-20 minutes)
  • Clinical instability at time of CT study acquisition
  • Women of childbearing potential
  • Personal or social problems that might prevent compliance with the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00583284

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Srikanth Sola The Cleveland Clinic
  More Information

Publications:
Responsible Party: Srikanth Sola, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583284     History of Changes
Other Study ID Numbers: Delayed Enhancement CT, IRB 06-647, Delayed CT and VT ablation
Study First Received: December 20, 2007
Last Updated: June 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
delayed enhancement computed tomography
ventricular tachycardia ablation
ventricular tachycardia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014