A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

• Sponsor: Lantheus Medical Imaging (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00625365
• Collaborator: (none)
• Enrollment: 1,060
• Locations: 16
• Arm: 1
• Duration (Months): 17
• Patients Per Site: 66.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: DEFINITY®	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1060 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: DEFINITY® (Perflutren Lipid Microsphere) Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography	Drug: DEFINITY®; DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert; Other Names: DEFINITY Perflutren Lipid Microsphere injectable suspension

Outcome Measures

Primary Outcome Measures

1. The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration [during or within 30 minutes of administration]

Secondary Outcome Measures

1. Serious Adverse Events [Through 24 hours]

   Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration

2. Adverse Events [Through 24 hours]

   Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.

Exclusion criteria

• Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.

• Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center	San Diego	California	United States	92103-8411
2	Alfieri Cardiology	Newark	Delaware	United States	19713
3	Northwestern University	Chicago	Illinois	United States	60611-2969
4	Maine Research Associates	Auburn	Maine	United States	04210
5	Park Nicolett Institute	Saint Louis Park	Minnesota	United States	55426
6	Cardiovascular Consultants, P.C.	Kansas City	Missouri	United States	64111
7	St. Louis University	Saint Louis	Missouri	United States	63110
8	St. Luke's-Roosevelt Hospital	New York	New York	United States	10025
9	Mt Sinai Medical Center	New York	New York	United States	10029
10	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
11	Meritcare Heart Center Cardiology	Fargo	North Dakota	United States	58122
12	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
13	York Hospital	York	Pennsylvania	United States	17405
14	Consultants in Cardiology	Fort Worth	Texas	United States	76104
15	University of Texas Medical Center	Galveston	Texas	United States	77555
16	The Methodist DeBakey Heart Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Lantheus Medical Imaging

Investigators

• Study Director: Veronica Lee, MD, Lantheus Medical Imaging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lantheus Medical Imaging
• ClinicalTrials.gov Identifier: NCT00625365
• Other Study ID Numbers: DMP 115-415
• First Posted: Feb 28, 2008
• Last Update Posted: Nov 24, 2020
• Last Verified: Aug 1, 2011

• Keywords provided by Lantheus Medical Imaging: DEFINITY; Safety; Survelliance
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Recruitment Details	Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009
Pre-assignment Detail	There were no pre-assignment requirements for this study

Arm/Group Title	DEFINITY®
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Period Title: Overall Study
STARTED	1060
COMPLETED	1053
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	DEFINITY (Perflutren Lipid Microsphere)
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Overall Participants	1053
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	609 57.8%
>=65 years	444 42.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (12.9)
Sex: Female, Male (Count of Participants)
Female	400 38%
Male	653 62%

Outcome Measures

1. Primary Outcome

Title	The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
Time Frame	during or within 30 minutes of administration

Outcome Measure Data

Analysis Population Description

The safety population was analyzed per the protocol

Arm/Group Title	DEFINITY®
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Measure Participants	1053
Number [Participants]	0 0%

2. Secondary Outcome

Title	Serious Adverse Events
Description	Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
Time Frame	Through 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEFINITY®
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Measure Participants	1053
Number [Participants]	0 0%

3. Secondary Outcome

Title	Adverse Events
Description	Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
Time Frame	Through 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEFINITY®
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Measure Participants	1053
Number [Participants]	114 10.8%

Adverse Events

Time Frame	Through 24 hours post last dose
Arm/Group Title	DEFINITY®
Arm/Group Description	Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
All Cause Mortality
	DEFINITY®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DEFINITY®
	Affected / at Risk (%)	# Events
Total	0/1053 (0%)
Other (Not Including Serious) Adverse Events
	DEFINITY®
	Affected / at Risk (%)	# Events
Total	35/1053 (3.3%)
Gastrointestinal disorders
Nausea	9/1053 (0.9%)	9
Musculoskeletal and connective tissue disorders
Back Pain	7/1053 (0.7%)	7
Nervous system disorders
Headache	13/1053 (1.2%)	13
Tremor	6/1053 (0.6%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.