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).

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Iodofiltic acid I 123

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada
  • Ontario
    • Scarborough, Ontario, Canada
• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Huntsville, Alabama, United States
  • Arizona
    • Mesa, Arizona, United States
  • California
    • Los Angeles, California, United States
    • Mission Viejo, California, United States
    • Newport Beach, California, United States
    • Roseville, California, United States, 95661
  • Connecticut
    • Hartford, Connecticut, United States
    • New Haven, Connecticut, United States
  • Delaware
    • Newark, Delaware, United States
  • Florida
    • Jacksonville, Florida, United States
  • Illinois
    • Aurora, Illinois, United States
    • Maywood, Illinois, United States
  • Kentucky
    • Louisville, Kentucky, United States, 40207
  • Maine
    • Auburn, Maine, United States
  • Maryland
    • Bethesda, Maryland, United States
  • Michigan
    • Detroit, Michigan, United States
    • Royal Oak, Michigan, United States
    • Troy, Michigan, United States, 48085
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
  • New Hampshire
    • Lebanon, New Hampshire, United States
    • Manchester, New Hampshire, United States
  • New York
    • Albany, New York, United States
    • Brooklyn, New York, United States
    • Kingston, New York, United States
    • New York, New York, United States
    • Rochester, New York, United States
    • Syracuse, New York, United States, 13210
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
  • Rhode Island
    • Providence, Rhode Island, United States
  • Texas
    • Houston, Texas, United States
  • Virginia
    • Richmond, Virginia, United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• <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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iodofiltic Acid I 123	Drug: Iodofiltic acid I 123

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Investigators: Study Director: Norman LaFrance, MD, Molecular Insight Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 8, 2007
• First Submitted That Met QC Criteria: August 9, 2007
• First Posted (Estimate): August 10, 2007

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: MIP-BP23