Cardiovascular DiseasePhase 4NCT00625365
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
A Phase 4 study testing DEFINITY® in people with Cardiovascular Disease, run by Lantheus Medical Imaging at 16 sites in United States.
Trial summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- DEFINITY®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2008to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.
Who cannot join
- Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
- Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Maine Research Associates
Auburn, Maine, 04210
Northwestern University
Chicago, Illinois, 60611-2969
Meritcare Heart Center Cardiology
Fargo, North Dakota, 58122
Consultants in Cardiology
Fort Worth, Texas, 76104
University of Texas Medical Center
Galveston, Texas, 77555
The Methodist DeBakey Heart Center
Houston, Texas, 77030
Cardiovascular Consultants, P.C.
Kansas City, Missouri, 64111
St. Luke's-Roosevelt Hospital
New York, New York, 10025
Mt Sinai Medical Center
New York, New York, 10029
Alfieri Cardiology
Newark, Delaware, 19713
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Park Nicolett Institute
Saint Louis Park, Minnesota, 55426
UCSD Medical Center
San Diego, California, 92103-8411
St. Louis University
St Louis, Missouri, 63110
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
York Hospital
York, Pennsylvania, 17405
About this study
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
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
- Conditions
- Cardiovascular Disease
- Being tested
- DEFINITY®
- Keywords
- DEFINITY, Safety, Survelliance
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFINITY®Drug
Also called DEFINITY, Perflutren Lipid Microsphere injectable suspension
DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
| Study group | Role | What they receive |
|---|---|---|
| DEFINITY® (Perflutren Lipid Microsphere) | Other | Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography Receives: Drug: DEFINITY® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
Measured: during or within 30 minutes of administration
Secondary outcomes (2)
Serious Adverse Events
Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
Measured: Through 24 hours
Adverse Events
Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
Measured: Through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Lee, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625365
- Sponsor's protocol ID
- DMP 115-415
- Status last verified
- Aug 2011
- First submitted
- 20 Feb 2008
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00625365
- Acronym / sponsor ID
- DMP 115-415
- Conditions
- Cardiovascular Disease
- Keywords
- DEFINITY, Safety, Survelliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 14 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEFINITY® (Perflutren Lipid Microsphere) | Other | Drug: DEFINITY®Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.
Key exclusion criteria (2 listed)
- Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
- Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEFINITY®Also: DEFINITY, Perflutren Lipid Microsphere injectable suspensionDEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert | Drug | DEFINITY® (Perflutren Lipid Microsphere) |
Primary outcome
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
2 secondary outcomes
Serious Adverse Events
Time frame: Through 24 hours
Adverse Events
Time frame: Through 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Lee, MD study director
Lantheus Medical Imaging
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEFINITY® in people with Cardiovascular Disease, run by Lantheus Medical Imaging at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.