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A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure

NCT00918866 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-11-24

Study results available
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Summary

The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.

Conditions

  • Pulmonary Heart Disease

Interventions

DRUG

Definity

one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight

Sponsors & Collaborators

  • Lantheus Medical Imaging

    lead INDUSTRY

Principal Investigators

  • Veronica Lee, MD · Lantheus Medical Imaging

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918866 on ClinicalTrials.gov