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

NCT ID: NCT00918866

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Heart Disease

Keywords

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Phase 4 DEFINITY® hemodynamics pulmonary artery pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low Pulmonary Arterial Pressure

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

Group Type EXPERIMENTAL

Definity

Intervention Type DRUG

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

Elevated Pulmonary Arterial Pressure

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

Group Type EXPERIMENTAL

Definity

Intervention Type DRUG

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

Interventions

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Definity

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

Intervention Type DRUG

Other Intervention Names

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Perflutren Lipid Microsphere

Eligibility Criteria

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Inclusion Criteria

* 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:

1. are not pregnant and have been using an adequate and medically approved method of contraception
2. have a negative urine pregnancy test
* Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Lee, MD

Role: STUDY_DIRECTOR

Lantheus Medical Imaging

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Methodist Hospital

Saint Louis Park, Minnesota, United States

Site Status

Cardiovascular Consultants

Kansas City, Missouri, United States

Site Status

Holy Name Hospital

Teaneck, New Jersey, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oregon Health and Sciences University

Portland, Oregon, United States

Site Status

The University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DMP 115-416

Identifier Type: -

Identifier Source: org_study_id