Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
Zeus-ACS
Open-label, Phase 2 Study of the Safety and Efficacy of B-methyl-P-(123I)- Iodophenyl-pentadecanoic Acid (Iodofiltic Acid I 123) For Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (Spect) in Adults With Symptoms Consistent With Acute Coronary Syndrome (ACS).
1 other identifier
interventional
510
2 countries
38
Brief Summary
This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 25, 2016
CompletedMarch 31, 2016
February 1, 2016
1.1 years
August 8, 2007
December 15, 2015
February 29, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30
Study Arms (1)
Iodofiltic Acid I 123
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent and are willing to comply with protocol requirements
- Are 40 years of age or older.
- Are being evaluated for possible ACS.
- If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.
You may not qualify if:
- \<40 years of age.
- Females who are pregnant or lactating.
- History of left ventricular ejection fraction (LVEF)=40%.
- History of MI.
- Acute ST segment elevation on ECG.
- Left bundle branch block on ECG.
- Known history of significant allergy to x-ray contrast media or iodine/iodides.
- Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
- Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
- Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
- Serum creatinine level \>2.0 mg per dL.
- Received investigational compound and/or medical device within 30 days of admission into this study.
- Q-wave abnormalities consistent with previous MI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Aurora, Illinois, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
Louisville, Kentucky, 40207, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Troy, Michigan, 48085, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Manchester, New Hampshire, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Kingston, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
North Vancouver, British Columbia, Canada
Unknown Facility
Scarborough Village, Ontario, Canada
Related Publications (1)
Kontos MC, Dilsizian V, Weiland F, DePuey G, Mahmarian JJ, Iskandrian AE, Bateman TM, Heller GV, Ananthasubramaniam K, Li Y, Goldman JL, Armor T, Kacena KA, LaFrance ND, Garcia EV, Babich JW, Udelson JE. Iodofiltic acid I 123 (BMIPP) fatty acid imaging improves initial diagnosis in emergency department patients with suspected acute coronary syndromes: a multicenter trial. J Am Coll Cardiol. 2010 Jul 20;56(4):290-9. doi: 10.1016/j.jacc.2010.03.045.
PMID: 20633821DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director of Clinical Communications
- Organization
- Progenics Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Norman LaFrance, MD
Molecular Insight Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 10, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2008
Study Completion
December 1, 2008
Last Updated
March 31, 2016
Results First Posted
January 25, 2016
Record last verified: 2016-02