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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00288756
Other study ID # 01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received February 7, 2006
Last updated September 11, 2006
Start date July 2006
Est. completion date August 2006

Study information

Verified date September 2006
Source Trillium Health Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical 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?


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?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 156
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Procedure:
lv injection of contrast


Locations

Country Name City State
Canada Trillium Health Centre Mississauga Ontario

Sponsors (1)

Lead Sponsor Collaborator
Trillium Health Centre

Country where clinical trial is conducted

Canada, 

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