Trial · NCT00730964
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
NCT00730964, Phase 4, Completed, GE Healthcare; results first posted 2012-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. Trials, record NCT00730964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
- NCT number
- NCT00730964
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,039 participants, actual
- Lead sponsor
- GE Healthcare
- Conditions
- Echocardiography
- Interventions
- Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
- First posted
- 2008-08-08
- Last updated
- 2012-06-12
- Results first posted
- 2012-06-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction. |
| Secondary | The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | Serious Adverse Reactions | NUMBER | |
| SECONDARY | The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Within 24 hours post contrast administration | Serious adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Arm 1 - Optison | 0 | Serious Adverse Reactions | ||
The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice. | Arm 1 - Optison | 6 | Serious adverse events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 - Optison | 1,039 | |
| Overall Study | COMPLETED | Arm 1 - Optison | 1,039 | |
| Overall Study | NOT COMPLETED | Arm 1 - Optison | 0 |
Source ClinicalTrials.gov
Adverse events7
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 | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm 1 - Optison | 69 | 1,039 | 288 |
| serious | Non-sustained ventricular tachycardia | Cardiac disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
| serious | Left Ventricular thrombus | Cardiac disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
| serious | Fluid Overload | Vascular disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
| serious | Coronary Artery Disease | Cardiac disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
| serious | Left Ventricular Mass Requiring Surgery | Cardiac disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
| serious | Episodes of Sustained Ventricular Tachycardia | Cardiac disorders | Arm 1 - Optison | 1 | 1,039 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 - Optison | ||
| Total, other adverse events | Arm 1 - Optison | 69 | 1,039 |
| Total, serious adverse events | Arm 1 - Optison | 5 | 1,039 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00730964
GET https://conductscience.org/api/trials/v1/NCT00730964/registered