Trial · NCT00918866
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
NCT00918866, Phase 4, Completed, Lantheus Medical Imaging; results first posted 2011-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure. Trials, record NCT00918866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00918866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
- NCT number
- NCT00918866
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 32 participants, actual
- Lead sponsor
- Lantheus Medical Imaging
- Conditions
- Pulmonary Heart Disease
- Interventions
- Definity
- First posted
- 2009-06-11
- Last updated
- 2020-11-24
- Results first posted
- 2011-07-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | 31-35 minutes minus baseline | Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose |
| Secondary | Immunology Panel- Complement 3A (C3A) | Out to 70 minutes | Evaluate the Immunology Panel after the administration of DEFINITY |
| Secondary | Immunology Panel- Complement 5A(C5A) | Out to 70 minutes | Evaluate the Immunology Panel after the administration of DEFINITY |
| Secondary | Immunology Panel- Interleuken-6 | Out to 70 minutes | Evaluate the Immunology Panel after the administration of DEFINITY |
| Secondary | Immunology Panel- Tryptase | Out to 70 minutes | Evaluate the Immunology Panel after the administration of DEFINITY |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | 31-35 minutes minus baseline | Per the protocol | mm Hg | MEAN |
| SECONDARY | Immunology Panel- Complement 3A (C3A) | Out to 70 minutes | ng/ml | MEAN | |
| SECONDARY | Immunology Panel- Complement 5A(C5A) | Out to 70 minutes | ng/ml | MEAN | |
| SECONDARY | Immunology Panel- Interleuken-6 | Out to 70 minutes | pg/ml | MEAN | |
| SECONDARY | Immunology Panel- Tryptase | Out to 70 minutes | ug/ml | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | Low Pulmonary Arterial Pressure | -1.9 | Standard Deviation 18.03 | mm Hg | |
| Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose | Elevated Pulmonary Arterial Pressure | -1.7 | Standard Deviation 10.25 | mm Hg | |
| Immunology Panel- Complement 3A (C3A) | Low Pulmonary Arterial Pressure | -45.80 | Standard Deviation 338.14 | ng/ml | |
| Immunology Panel- Complement 3A (C3A) | Elevated Pulmonary Arterial Pressure | -38.20 | Standard Deviation 414.86 | ng/ml | |
| Immunology Panel- Complement 5A(C5A) | Low Pulmonary Arterial Pressure | -0.95 | Standard Deviation 3.56 | ng/ml | |
| Immunology Panel- Complement 5A(C5A) | Elevated Pulmonary Arterial Pressure | 0.78 | Standard Deviation 4.55 | ng/ml | |
| Immunology Panel- Interleuken-6 | Low Pulmonary Arterial Pressure | 0.31 | Standard Deviation 1.46 | pg/ml | |
| Immunology Panel- Interleuken-6 | Elevated Pulmonary Arterial Pressure | 0.15 | Standard Deviation 2.11 | pg/ml | |
| Immunology Panel- Tryptase | Low Pulmonary Arterial Pressure | -0.24 | Standard Deviation 0.82 | ug/ml | |
| Immunology Panel- Tryptase | Elevated Pulmonary Arterial Pressure | -0.01 | Standard Deviation 1.46 | ug/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Pulmonary Arterial Pressure | 16 | |
| Overall Study | STARTED | Elevated Pulmonary Arterial Pressure | 16 | |
| Overall Study | COMPLETED | Low Pulmonary Arterial Pressure | 16 | |
| Overall Study | COMPLETED | Elevated Pulmonary Arterial Pressure | 16 | |
| Overall Study | NOT COMPLETED | Low Pulmonary Arterial Pressure | 0 | |
| Overall Study | NOT COMPLETED | Elevated Pulmonary Arterial Pressure | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest Pain | General disorders | Low Pulmonary Arterial Pressure | 0 | 16 | 0 |
| other | Chest Pain | General disorders | Elevated Pulmonary Arterial Pressure | 1 | 16 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Low Pulmonary Arterial Pressure | 1 | 16 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Elevated Pulmonary Arterial Pressure | 1 | 16 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Low Pulmonary Arterial Pressure | 2 | 16 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Elevated Pulmonary Arterial Pressure | 3 | 16 | 3 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Low Pulmonary Arterial Pressure | 0 | 16 | 0 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Elevated Pulmonary Arterial Pressure | 1 | 16 | 1 |
| other | Dizziness | Nervous system disorders | Low Pulmonary Arterial Pressure | 1 | 16 | 1 |
| other | Dizziness | Nervous system disorders | Elevated Pulmonary Arterial Pressure | 0 | 16 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Pulmonary Arterial Pressure | ||
| Total, all-cause mortality | Elevated Pulmonary Arterial Pressure | ||
| Total, other adverse events | Low Pulmonary Arterial Pressure | 4 | 16 |
| Total, other adverse events | Elevated Pulmonary Arterial Pressure | 5 | 16 |
| Total, serious adverse events | Low Pulmonary Arterial Pressure | 0 | 16 |
| Total, serious adverse events | Elevated Pulmonary Arterial Pressure | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Low Pulmonary Arterial Pressure vs Elevated Pulmonary Arterial Pressure: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00918866
GET https://conductscience.org/api/trials/v1/NCT00918866/registered