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

Acute Coronary Syndrome Clinical Trial

— Zeus-ACS  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514501
• Other study ID #: MIP-BP23
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: December 15, 2015
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2015
• Source: Molecular Insight Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Iodofiltic acid I 123

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Insight Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity of Detecting Myocardial Ischemia		baseline, 30 days	No