NCT01310517

Brief Summary

The purpose of the study is to directly compare two methods of evaluating heart function at the time of your angiogram. In both methods contrast dye is injected into the main heart chamber during the angiogram while x-ray images are taken. One method uses an automatic power injector to deliver the normal volume of contrast; the other method uses hand injection of very low volume of contrast into the main heart chamber. It is hypothesized that hand injection will prove to be an accurate method to estimate ejection fraction (EF) at the time of radial coronary angiography when compared directly to Power LV.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 2, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

March 7, 2011

Last Update Submit

October 1, 2014

Conditions

Keywords

AngiogramInjected ContrastHeart Functioncontrast dye

Outcome Measures

Primary Outcomes (1)

  • Imaging comparison

    End of study

Study Arms (1)

Radial Coronary Angiography

The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects enrolled in this study will be adults referred for radial coronary angiography with left ventriculography for clinical indications.

You may qualify if:

  • Adult patients greater than 18 years of age referred for radial coronary angiography with left ventriculography for clinical indications at the Loma Linda Heart and Surgical Hospital or the Loma Linda University Medical Center will be included in this study.

You may not qualify if:

  • Patients with a prosthetic aortic valve
  • Patients with severe aortic stenosis
  • Patients with suspected left main coronary artery disease
  • Patients with other contraindications to left ventriculography.
  • Patients with chronic kidney disease with a baseline creatinine ≥2.0 mg/dl if not already on renal replacement therapy will also be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Study Officials

  • Anthony A Hilliard, MD

    Loma Linda University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 2, 2014

Record last verified: 2014-10

Locations