Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2008

Interventions Used in this Clinical Trial

  • Drug: Iodofiltic acid I 123

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Iodofiltic Acid I 123

Outcome Measures for this Clinical Trial

Primary Measures

  • Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
    • Time Frame: Day 30
      Safety Issue?: No
  • Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
    • Time Frame: Day 30
      Safety Issue?: No
  • Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
    • Time Frame: Day 30
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Molecular Insight Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Norman LaFrance, MD, Study Director, Molecular Insight Pharmaceuticals, Inc.


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