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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 19, 2013