Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00918866 |
| Other study ID # |
DMP 115-416 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 2009 |
| Est. completion date |
December 2009 |
Study information
| Verified date |
October 2011 |
| Source |
Lantheus Medical Imaging |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This Phase IV safety study will provide safety data on potential systemic and pulmonary
hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo
right heart cardiac catheterization for clinical reasons. Using a right heart catheter for
direct measurements of pulmonary artery hemodynamics will allow accurate assessments of
potential alterations of the pulmonary vasculature. This will be further investigated by the
inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35
mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune
parameter measurements will assess a potential link between systemic and pulmonary
alterations and potential immune reactions following DEFINITY® administration.
The inclusion of patients in this study is not based on a required echocardiogram with
DEFINITY® administration because patients would be exposed to an unjustifiable risk of
invasive right heart catheterization and are unlikely to consent to such a procedure.
Therefore, patients undergoing heart catheterization for clinical reasons, or patients who
are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive
DEFINITY® in this study.
