Clinical trial NCT00514501: Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 510
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
timeFrame: Day 30
measure: Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
timeFrame: Day 30
measure: Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Jacksonville
country: United States
state: Florida
city: Aurora
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Bethesda
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Manchester
country: United States
state: New Hampshire
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Providence
country: United States
state: Rhode Island
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: North Vancouver
country: Canada
state: British Columbia
city: Scarborough
country: Canada
state: Ontario
Study officials:
affiliation: Molecular Insight Pharmaceuticals, Inc.
name: Norman LaFrance, MD
role: STUDY_DIRECTOR
References:
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.