A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Completed · Phase 4
Conditions studied: Pulmonary Heart Disease
In brief
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.
Key facts
- Study ID
- NCT00918866
- Run by
- Lantheus Medical Imaging
- People needed
- 32
- Starts
- 2009-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2020-11-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
- Be male or female above the age of 18
- Female patients who no longer have child-bearing potential
- Women of Child-Bearing Potential(WOCBP) who:
- are not pregnant and have been using an adequate and medically approved method of contraception
- have a negative urine pregnancy test
- Be able and willing to communicate effectively with study center personnel.
You may not qualify if…
- Women who are pregnant or lactating
- Known hypersensitivity or contraindication to or greater heart block
- Previous heart transplant
- Known right-to-left shunt (including atrial septal defect)
- Severe pulmonary artery hypertension (i.e., > 75 mmHg
- Current uncontrolled ventricular tachycardia
- Second-degree or greater heart block
- Any contraindications for the use of a right heart catheter
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Methodist Hospital — Saint Louis Park, Minnesota, United States
- Cardiovascular Consultants — Kansas City, Missouri, United States
- Holy Name Hospital — Teaneck, New Jersey, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Oregon Health and Sciences University — Portland, Oregon, United States
- The University of Texas Medical Branch at Galveston — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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