NCT00918866

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 11, 2011

Completed
Last Updated

November 24, 2020

Status Verified

October 1, 2011

Enrollment Period

5 months

First QC Date

June 4, 2009

Results QC Date

December 17, 2010

Last Update Submit

November 6, 2020

Conditions

Pulmonary Heart Disease

Keywords

Phase 4DEFINITY®hemodynamicspulmonary artery pressure

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose

    Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose

    31-35 minutes minus baseline

Secondary Outcomes (4)

  • Immunology Panel- Complement 3A (C3A)

    Out to 70 minutes

  • Immunology Panel- Complement 5A(C5A)

    Out to 70 minutes

  • Immunology Panel- Interleuken-6

    Out to 70 minutes

  • Immunology Panel- Tryptase

    Out to 70 minutes

Study Arms (2)

Low Pulmonary Arterial Pressure

EXPERIMENTAL

Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.

Drug: Definity

Elevated Pulmonary Arterial Pressure

EXPERIMENTAL

Subjects with a PAP of \> or = to 35 mmHg.

Drug: Definity

Interventions

DefinityDRUG

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

Also known as: Perflutren Lipid Microsphere
Elevated Pulmonary Arterial PressureLow Pulmonary Arterial Pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Location

Holy Name Hospital

Teaneck, New Jersey, 07666, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Pulmonary Heart Disease

Interventions

perflutren

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dana Washburn, M.D.
Organization
Lantheus Medical Imaging
dana.washburn@lantheus.com
978-671-8686

Study Officials

  • Veronica Lee, MD

    Lantheus Medical Imaging

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 11, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 24, 2020

Results First Posted

July 11, 2011

Record last verified: 2011-10

Locations

US(8)