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

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00625365

Purpose

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

Condition	Intervention	Phase
Cardiovascular Disease	Other: Perflutren Lipid Microspheres (DEFINITY®)	Phase IV

Drug Information available for: Octafluoropropane Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment, Safety 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

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1600
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625365

Contacts

Contact: Lisa O'Loughlin	800-588-5744 ext 8274	lisa.oloughlin@bms.com
Contact: Sharon Cooke	800-588-5744 ext 8273	sharon.cooke@bms.com

Locations

United States, California
UCSD Medical Center	Recruiting
San Diego, California, United States, 92103-8411
Contact: Anthony DeMaria, MD 619-543-6031 MHAIGLER@ucsd.edu
Principal Investigator: Anthony DeMaria, MD
United States, Delaware
Alfieri Cardiology	Recruiting
Newark, Delaware, United States, 19713
Contact: Paul Alfieri, MD 302-731-0001 palfieri111@comcast.net
Contact: Colleen Buchanan 302-731-0001 buchshark@aol.com
Principal Investigator: Paul Alfieri, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611-2969
Contact: Issam Mikati, MD 312-695-0025 t-mikati@northwestern.edu
Contact: Karissa Fortney, RN 312-926-4801 kfortney@nmh.org
Principal Investigator: Issam Mikati, MD
United States, Maine
Maine Research Associates	Recruiting
Auburn, Maine, United States, 04210
Contact: Robert J Weiss, MD 207-782-9835 rweuss/@exploremaine.com
Contact: Marissa Tardiff, RN, BSN 207-782-9835 tardifm@midmaine.com
Principal Investigator: Robert J Weiss, MD
United States, Minnesota
Park Nicolett Institute	Recruiting
St Louis Park, Minnesota, United States, 55426
Contact: Elizabeth Bisinov, MD 952-231-3839 barnesm@parknicollet.com
Principal Investigator: Elizabeth Bisinov, MD
United States, Missouri
Cardiovascular Consultants, P.C.	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Michael Main, MD 816-751-8545 mmain@cc-pc.com
Contact: Lynne Comer 816-932-5959 lycomer@cc-pc.com
Principal Investigator: Michael Main, MD
United States, New York
St. Luke's-Roosevelt Hospital	Recruiting
New York, New York, United States, 10025
Contact: Farooq Chaudhry 212-523-4296 fchaudhry@chpnet.org
Contact: Robin Knox, RN 212- 523-3253 rknox@chpnet.org
Principal Investigator: Farooq Chaudhry, MD
Mt Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Martin Goldman, MD 212-241-3078 Samantha.Buckley@mountsinai.org
Principal Investigator: Martin Goldman, MD
United States, North Carolina
Wake Forest University Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Dalane Kitzman, MD 336-716-3274 dkitzman@wfubmc.edu
Contact: Kathy Stewart 336-716-6339 kstewart@wfubmc.edu
Principal Investigator: Dalane Kitzman, MD
United States, Pennsylvania
York Hospital	Recruiting
York, Pennsylvania, United States, 17405
Contact: James Mills, MD 717-851-3472 jmills@wellspan.0rg
Contact: Barbara Delio-Cox, RN 717-851-3472 bdeliocox@wellspan.org
Principal Investigator: James Mills, MD
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Flordeliza Villanueva, MD 412-647-5840 villanuevafs@upmc.edu
Contact: Louise DeRiso 412-647-5344 derisol@upmc.edu
Principal Investigator: Flordeliza Villanueva, MD
United States, Texas
Consultants in Cardiology	Recruiting
Fort Worth, Texas, United States, 76104
Contact: David Parrish, MD 817-252-5067 davidparrish@mac.com
Contact: Debbie McEntire 817-252-5067 tweetebear@sbcglobal.net
Principal Investigator: David Parrish, MD
The Methodist DeBakey Heart Center	Recruiting
Houston, Texas, United States, 77030
Contact: SuMin Chang, MD 713-441-3625 SMChang@tmhs.org
Contact: Denise Meeks 713-441-2107 dmeeks@tmhs.org
Principal Investigator: SuMin Chang, MD
University of Texas Medical Center	Recruiting
Galveston, Texas, United States, 77555
Contact: Masood Ahmad, MD 409-772-2590 mahmad@utmb.edu
Contact: Leo Dimaano 409-772-2588 mmdimaan@utmb.edu
Principal Investigator: Masood Ahmad, MD

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators

Study Director:

Qi Zhu, MD

Lantheus Medical Imaging

More Information

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, Medical Director )
Study ID Numbers:	DMP 115-415
Study First Received:	February 20, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00625365
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:

DEFINITY
Safety
Survelliance

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009