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

January 19, 2017 updated by: The Cleveland Clinic

Utility of Delayed-Enhancement Multi-Detector Computed Tomography Imaging in Identifying Arrhymogenic Substrate in Patients Undergoing Catheter Ablation for Ventricular Tachycardia

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

4

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

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients coming to Cleveland Clinic for catheter ablation for ventricular tachycardia

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 week

Collaborators and Investigators

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

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Srikanth Sola, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Ventricular Tachycardia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe