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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Iodofiltic acid I 123
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iodofiltic Acid I 123

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2007
Last Updated
February 29, 2016
Sponsor
Molecular Insight Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00514501
Brief Title
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iodofiltic Acid I 123
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Iodofiltic acid I 123
Primary Outcome Measure Information:
Title
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Description
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.
Time Frame
Day 30
Title
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
Description
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.
Time Frame
Day 30
Title
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
Description
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.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman LaFrance, MD
Organizational Affiliation
Molecular Insight Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Mission Viejo
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Hartford
State/Province
Connecticut
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Newark
State/Province
Delaware
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Aurora
State/Province
Illinois
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Manchester
State/Province
New Hampshire
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Kingston
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
North Vancouver
State/Province
British Columbia
Country
Canada
City
Scarborough
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20633821
Citation
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.
Results Reference
derived

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

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