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

NCT ID: NCT00514501

Last Updated: 2016-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iodofiltic Acid I 123

Group Type EXPERIMENTAL

Iodofiltic acid I 123

Intervention Type DRUG

Interventions

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Iodofiltic acid I 123

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molecular Insight Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norman LaFrance, MD

Role: STUDY_DIRECTOR

Molecular Insight Pharmaceuticals, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Huntsville, Alabama, United States

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Mesa, Arizona, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Newport Beach, California, United States

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Roseville, California, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Aurora, Illinois, United States

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Maywood, Illinois, United States

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Louisville, Kentucky, United States

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Auburn, Maine, United States

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Bethesda, Maryland, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Lebanon, New Hampshire, United States

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Manchester, New Hampshire, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Kingston, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Providence, Rhode Island, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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North Vancouver, British Columbia, Canada

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Scarborough Village, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 20633821 (View on PubMed)

Other Identifiers

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MIP-BP23

Identifier Type: -

Identifier Source: org_study_id

NCT00585663

Identifier Type: -

Identifier Source: nct_alias

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