Ventricular TachycardiaNCT00583284
The Use of CT to Identify Damaged Heart Muscle in Patients Undergoing Ventricular Tachycardia Ablation.
An observational study of Ventricular Tachycardia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventricular Tachycardia
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients coming to Cleveland Clinic for catheter ablation for ventricular tachycardia
Who may be able to join
- Age > 21 years
- Prior myocardial infarction
- Scheduled for CT scan < 1 week prior to VT ablation for ventricular arrythmia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Tachycardia
- Keywords
- delayed enhancement computed tomography, ventricular tachycardia ablation, ventricular tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: key study staff left foundation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srikanth Sola, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583284
- Sponsor's protocol ID
- 06-647
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2007
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002. doi: 10.1161/01.cir.100.19.1992.
PubMed 10556226
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Delayed-Enhancement Multi-Detector Computed Tomography Imaging in Identifying Arrhymogenic Substrate in Patients Undergoing Catheter Ablation for Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT00583284
- Acronym / sponsor ID
- 06-647
- Conditions
- Ventricular Tachycardia
- Keywords
- delayed enhancement computed tomography, ventricular tachycardia ablation, ventricular tachycardia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: key study staff left foundation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2006 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to Cleveland Clinic for catheter ablation for ventricular tachycardia
Key inclusion criteria (3 listed)
- Age > 21 years
- Prior myocardial infarction
- Scheduled for CT scan < 1 week prior to VT ablation for ventricular arrythmia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: key study staff left foundation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Background: PubMed 10556226Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002. doi: 10.1161/01.cir.100.19.1992.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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Assessment of Combined CCM and ICD Device in HFrEF
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Genetic Markers of Cardiovascular Disease in Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srikanth Sola principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: key study staff left foundation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.