Trial Outcomes & Findings for A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. (NCT NCT00730964)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1039 participants

Primary outcome timeframe

Within 24 hours post contrast administration

Results posted on

2012-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 - Optison Open Label with 1039 subjects that received Optison to evaluate the safety of the product
Overall Study STARTED	1039
Overall Study COMPLETED	1039
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Optison n=1039 Participants Open Label with 1039 subjects that received Optison to evaluate the safety of the product
Age Continuous	59.9 years STANDARD_DEVIATION 12.99 • n=99 Participants
Age, Customized <=65 years	671 participants n=99 Participants
Age, Customized Between 65 and 75 years	227 participants n=99 Participants
Age, Customized >=75 years	141 participants n=99 Participants
Sex: Female, Male Female	391 Participants n=99 Participants
Sex: Female, Male Male	648 Participants n=99 Participants
Region of Enrollment United States	1039 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 - Optison n=1039 Participants Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
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.	0 Serious Adverse Reactions

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 - Optison n=1039 Participants Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
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.	6 Serious adverse events

Adverse Events

Arm 1 - Optison

Serious events: 5 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 - Optison n=1039 participants at risk Open Label with 1039 subjects that received Optison to evaluate the safety of the product
Cardiac disorders Non-sustained ventricular tachycardia	0.10% 1/1039 • Number of events 1
Cardiac disorders Left Ventricular thrombus	0.10% 1/1039 • Number of events 1
Vascular disorders Fluid Overload	0.10% 1/1039 • Number of events 1
Cardiac disorders Coronary Artery Disease	0.10% 1/1039 • Number of events 1
Cardiac disorders Left Ventricular Mass Requiring Surgery	0.10% 1/1039 • Number of events 1
Cardiac disorders Episodes of Sustained Ventricular Tachycardia	0.10% 1/1039 • Number of events 1

Other adverse events

Other adverse events
Measure	Arm 1 - Optison n=1039 participants at risk Open Label with 1039 subjects that received Optison to evaluate the safety of the product
Respiratory, thoracic and mediastinal disorders Dyspnea	6.6% 69/1039 • Number of events 288

Additional Information

Rubin Sheng, MD

GE Healthcare

Phone: 1-609-514-6899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place