Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (Zeus-ACS)

This study has been completed.
Sponsor:
Information provided by:
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00514501
First received: August 8, 2007
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Iodofiltic acid I 123
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Sensitivity, Specificity of detecting Myocardial Ischemia [ Time Frame: baseline, 30 days ]

Estimated Enrollment: 600
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514501

  Show 38 Study Locations
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Study Director: Norman LaFrance, MD Molecular Insight Pharmaceuticals, Inc.
  More Information

No publications provided by Molecular Insight Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00514501     History of Changes
Other Study ID Numbers: MIP-BP23
Study First Received: August 8, 2007
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014