Ventricular ArrythmiasNCT00288756
The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle
An observational study of Ventricular Arrythmias, run by Trillium Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality? Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventricular Arrythmias
- What is being tested?
- lv injection of contrast
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Aug 2006
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Only ventriculograms that the operator deems necessary for the booked procedure will be considered. Only operators agreeing to the for mentioned settings will participate in the study. Patients will be randomized consecutively and should conclude in 3 to 4 weeks.
Who cannot join
- Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality?
Read the detailed description
The LV angiogram is performed frequently as part of the cardiac catheterization procedure. It is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. This provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. A common occurrence when performing a LV angio is frequent PVC's or V-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) This is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam.
In an attempt to decrease the incidence of ventricular ectopic's during the LV angiogram Contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. Whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?
- Conditions
- Ventricular Arrythmias
- Being tested
- lv injection of contrast
- Keywords
- arrythmias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lv injection of contrastProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiasStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 156 participants
Sponsor and investigators
- Lead sponsor
- Trillium Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Peter Vandermyden, RN, Principal investigator, staff RN Trillium Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288756
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2006
- First submitted
- 7 Feb 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle
- ClinicalTrials.gov ID
- NCT00288756
- Acronym / sponsor ID
- 01
- Conditions
- Ventricular Arrythmias
- Keywords
- arrythmias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants
- Lead sponsor
- Trillium Health CentreUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Aug 2006
- First posted
- 8 Feb 2006 (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.
The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality?
Detailed description
The LV angiogram is performed frequently as part of the cardiac catheterization procedure. It is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. This provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. A common occurrence when performing a LV angio is frequent PVC's or V-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) This is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam.
In an attempt to decrease the incidence of ventricular ectopic's during the LV angiogram Contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. Whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Only ventriculograms that the operator deems necessary for the booked procedure will be considered. Only operators agreeing to the for mentioned settings will participate in the study. Patients will be randomized consecutively and should conclude in 3 to 4 weeks.
Key exclusion criteria (1 listed)
- Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lv injection of contrast | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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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.
Peter Vandermyden, RN principal investigator
staff RN Trillium Health Centre
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 Arrythmias, run by Trillium Health Centre at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2006. 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 Canada. 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?
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.
Where can I read the original study information?
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 13 Sep 2006.